Adult Clinical Research Protocols
Adj. Breast
CAMP 008 IRB# 7480
A randomized trial of cyclosporine alpha and interferon gamma versus low-dose IL-2 to eliminate
minimal residual breast cancer in patients undergoing high dose chemotherapy in complete remission
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Adj. Breast
CAMP 014 IRB# 7608
Phase III study of high dose chemotherapy followed by autologous hematopoietic stem cell support and
immunomodulation in women with high risk stage II and stage III breast cancer
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Adj. Breast
CPMC IRB# 13625
Hatha yoga and breast cancer: integrating a mind/body intervention during chemotherapy
PI: A Tiersten, MD Contact Person: Donna Russo
Adj. Breast
CPMC IRB# 13807
Cognitive effects of adjuvant chemotherapy in women with breast cancer
PI: F Tager, PhD Contact Person: Felice A. Tager, Ph.D.
Adj. Breast
SWOG 9927 IRB# 13815
Randomized trial of post-mastectomy radiotherapy in stage II breast cancer in women with one to
three positive axillary nodes, phase III
PI: P Schiff, MD Contact Person: Lisa Chin, MPH, JD
Adj. Breast
CPMC/NOVARTIS IRB# 14069
A randomized, placebo controlled trial of zoledronic acid for the prevention of bone loss in
pre-menopausal women with early stage breast cancer
PI: D Hershman, MD Contact Person: Laureen Shriberg
Loc. Adv. Breast
CAMP 014 IRB# 7608
Phase III study of high dose chemotherapy followed by autologous hematopoietic stem cell support and
immunomodulation in women with high risk stage II and stage III breast cancer
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Loc. Adv. Breast
SWOG R9804 IRB# 9804
Phase III trial of observation+/- tamoxifen vs. RT +/- tamoxifen for good risk duct carcinoma
in-situ (DCIS) of the female breast
PI: Horton Hospital, Contact Person: Denise Serrano
Loc. Adv. Breast
CAMP 100 IRB# 13645
High dose chemotherapy for patients with stage 2 high risk, locally advanced (stage 3) and
metastatic (stage 4) breast cancer (registry)
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Loc. Adv. Breast
CPMC/AVENTIS IRB# 13806
Phase II evaluation of bi-weekly administration of docetaxel combined with doxorubicin in patients
with locally advanced breast cancer
PI: A Tiersten, MD Contact Person: Laureen Shriberg
Met. Breast
CPMC IRB# 1508
Cardiovascular late effects of taxotere treatment in breast cancer patients
PI: R Sloan, MD Contact Person: Richard Sloan M.D.
Met. Breast
CAMP 100 IRB# 13645
High dose chemotherapy for patients with stage 2 high risk, locally advanced (stage 3) and
metastatic (stage 4) breast cancer (registry)
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Breast Non-specific
CPMC IRB# 7776
Antioxidant intervention in women at high risk of breast cancer
PI: L Mooney, MD Contact Person: LaVerne Mooney
Breast Non-specific
CPMC IRB# 8201
Social psychoeducation for minority women at high risk for breast cancer
PI: S Sheinfeld Gorin, PhD Contact Person: Sherri Gorin, PhD
Breast Non-specific
SWOG 9832 IRB# 8667
Enhanced well being during breast cancer recurrence
PI: V Grann, MD Contact Person: Yvette Ortiz-Pride
Breast Non-specific
CPMC IRB# 8786
Psychosocial deterents to breast cancer screening
PI: A Neugut, MD Contact Person: Alfred Neugut
Breast Non-specific
NSABP IRB# 9062
Protocol P-2: study of tamoxifen and raloxifene (STAR) for the prevention of breast cancer
PI: V Grann, MD Contact Person: Laureen Shriberg
Breast Non-specific
CPMC IRB# 9606
Attitudes toward mammography and breast cancer and compliance with screening guidelines in hispanic
women in Northern Manhattan
PI: A Neugut, MD Contact Person: Michael Cantor, M. D.
Breast Non-specific
CPMC IRB# 13609
Tamoxifen withdrawal: effect on bone mass in postmenopausal women with breast cancer
PI: S Silverberg, MD Contact Person: Dr. Adi Cohen
Breast Non-specific
SWOG N9831 IRB# 13761
A phase III trial of doxorubicin and cychlophosphamide followed by weekly paclitaxel with or without
trastuzumab as adjuvant treatment for women with HER-2 overexpressing node postive breast cancer
PI: A Tiersten, MD Contact Person: Yvette Ortiz-Pride
Breast Non-specific
CPMC IRB# 14432
Relationship between cardiac contracility, ejection fraction, cardiac output, and peripheral
vascular resistance in women undergoing treatment for breast cancer.
PI: D Hershman, MD Contact Person: Laureen Shriberg
Breast Non-specific
BRISTOL-MYERS SQUIBB IRB# 14519
A phase II trial of epothilone analog BMS-247550 in patients with metastatic breast cancer
previously treated with anthracycline
PI: A Tiersten, MD Contact Person: Laureen Shriberg
GYN
09/26/02
Cervix
CPMC/BRISTOL/SMITHKLINE IRB# 7919
Phase II investigation of topotecan and taxol in patients with recurrent metastatic cancer of the
cervix
PI: A Tiersten, MD Contact Person: Laureen Shriberg
Ovary
CAMP20/BMS/SKB IRB# 7866
PhaseI/II study of tandem cycles of high dose chemotherapy followed by autologous hematopoietic stem
cell support in women with persistent or recurrent advanced (stage III or IV) epithelial ovarian
cancer
PI: A Tiersten, MD Contact Person: Erin Sharpe
Ovary
CPMC/AVENTIS IRB# 8437
A phase II study of docetaxel and carboplatin for suboptimally debulked stage III or stage IV
ovarian and fallopian tube carcinoma
PI: A Tiersten, MD Contact Person: Laureen Shriberg
Ovary
SWOG 9912 IRB# 9423
Phase II evaluation of intravenous paclitaxel, intraperitoneal cisplatin, intravenous liposomal
doxorubicin and intraperitoneal paclitaxel in women with optimally-debulked stage III epithelial
ovarian cancer or primary peritoneal cancer
PI: A Tiersten, MD Contact Person: Yvette Ortiz-Pride
Ovary
SWOG S0009 IRB# 13833
A phase II evaluation of neoadjuvant chemotherapy, interval debulking followed by intraperitoneal
chemotherapy in women with stage III and IV epithelial ovarian cancer, fallopian tube cancer, or
primary peritoneal cancer
PI: A Tiersten, MD Contact Person: Yvette Ortiz-Pride
Other Female Genital
CPMC IRB# 13590
Investigation of potential new urinary markers of malignancy: isoforms of hCG
PI: S Birken, MD Contact Person: Steven Birken, MD
GU
09/26/02
Prostate
SWOG 9346 IRB# 7252
Intermittent androgen deprivation in patients with stage D2 prostate cancer, phase III
PI: M Benson, MD Contact Person: Anna Gavazzi, R.N.
Prostate
CPMC IRB# 7947
Phase II trial of maximal androgen deprivation followed by conformal external beam radiotherapy with
continued androgen deprivation for clinically localized prostate cancer
PI: R Ennis, MD Contact Person: Darleen Vecchio
Prostate
SWOG JPR07 IRB# 9296
A phase III randomized trial comparing intermittent vs. continuous androgen suppression for patients
with prostate-specific antigen progression in the clinical absence of distant metastases following
radiotherapy for prostate cancer
PI: M Benson, MD Contact Person: Alpa Tolia RN
Prostate
SWOG 9916 IRB# 9357
A phase III study of docetaxel and estramustine versus mitoxantrone and prednisone for advanced,
hormone-refractory prostate cancer
PI: D Petrylak, MD Contact Person: Jill
Muir
Prostate
NCI IRB# 9428
A double blind, randomized crossover phase II study of oral thalidomide vs. placebo in patients with
stage D0 androgen-dependent prostate cancer following limited hormonal ablation
PI: D Petrylak, MD Contact Person: Jill
Muir
Prostate
SWOG 9917 IRB# 9616
L-selenium-based chemoprevention of prostate cancer among men with high grade prostatic
intraepithelial neoplasia
PI: M Benson, MD Contact Person: Alpa Tolia RN
Prostate
SWOG 9921 IRB# 9718
Adjuvant androgen deprivation vs. mitoxantrone plus prednisone plus androgen deprivation in selected
high risk prostate cancer patients following radical prostatectomy, phase III
PI: D Petrylak, MD Contact Person: Jill
Muir
Prostate
PROTARGA INC. IRB# 13528
A phase II open-label study of taxoprexin (DHA-paclitaxel) injection by 2 hour intravenous infusion
in patients with metastatic hormone refractory prostate cancer
PI: D Petrylak, MD Contact Person: Jill
Muir
Prostate
SWOG S0000 IRB# 13553
Selenium and vitamin E cancer prevention trial (SELECT)
PI: M Benson, MD Contact Person: Erica Golliday
Prostate
GTX-006 IRB# 13814
A multicenter, phase IIb, four arm, dose finding, randomized, placebo-controlled study to determine
the long term prostate cancer chemoprevention efficacy and safety of 20mg, 40mg, and 60mg daily of
gtx-006 in men with high grade prostate intraepithlelial neoplasia (PIN)
PI: E Goluboff, MD Contact Person: Pat Meade-D'Alisera
Prostate
CELL PATHWAYS IRB# 13869
Phase II study of CP-461 in prostate cancer patients with measurable soft tissue disease
PI: D Petrylak, MD Contact Person: Jill
Muir
Prostate
NYH IRB# 13944
Phase II trial of mAb HuJ591 in combination with low dose subcutaneous interleukin-2 in patients
with recurrent prostate cancer
PI: D Petrylak, MD Contact Person: Jill
Muir
Prostate
ENDOCARE IRB# 14456
Pivotal study for the endocare horizon prostatic stent for the management of post-cryotherapy
urinary retention
PI: A Katz, MD Contact Person: Monica Kardos, R.N.
Prostate
NOVARTIS IRB# 14470
Zoledronic acid, transdermal estrogen or both for the prevention of bone loss in men undergoing
hormonal blockade therapy for prostate cancer
PI: E Shane, MD Contact Person: Dawn Hershman, M.D.
Urinary Bladder
CPMC/LILLY IRB# 8339
Phase I followed by phase II study of docetaxel, carboplatin, and gemcitabine combination
chemotherapy in patients with unresectable transitional cell carcinoma
PI: D Petrylak, MD Contact Person: Jill
Muir
Urinary Bladder
UMCC IRB# 9443
Phase II trial of paclitaxel, carboplatin, and gemcitabine in patients with locally advanced
transitional cell carcinoma of the bladder.
PI: D Petrylak, MD Contact Person: Jill
Muir
Urinary Bladder
NCI IRB# 9539
A phase II evaluation of rhuMAb (herceptin), paclitaxel, carboplatin and gemcitabine in the
treatment of advanced urothelial cancer
PI: D Petrylak, MD Contact Person: Jill
Muir
Urinary Bladder
SCHERING PLOUGH IRB# 13817
A multicenter trial of induction and 6 courses of 3 week maintenance with BCG versus BCG plus
interferon alfa-2B (intron A) in superficial bladder cancer
PI: M Benson, MD Contact Person: Alpa Tolia RN
Urinary Bladder
BANYU PHARMACEUTICAL,CO. IRB# 13863
A phase IIA study of the efficacy and tolerability of J-107088 in patients with metastatic
urothelial transitional cell carcinoma
PI: D Petrylak, MD Contact Person: Jill
Muir
Urinary Bladder
EISAI IRB# 14299
A phase II study of E7070 in patients with progressive inoperable and/or metastatic renal cell
carcinoma (RCC) (E7070-A001-206)
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Kidney
ARONEX IRB# 8782
Phase I/II trial of atragen and interferon alpha-2b in patients with advanced renal cell carcinoma
PI: D Petrylak, MD Contact Person: Jill
Muir
Kidney
CPMC IRB# 9469
A pilot study of dendritic cell based immunotherapy in patients with high-risk renal cancer
PI: K Papadopoulos, MD Contact Person: Janice Wen
Kidney
PROTARGA INC. IRB# 13529
A phase II open-label study of taxoprexin (DHA-paclitaxel) injection by 2-hour intravenous infusion
in patients with metastatic, locally advanced, or unresectable renal cell carcinoma
PI: D Petrylak, MD Contact Person: Jill
Muir
Kidney
ANTIGENETICS IRB# 13783
A multi-center, randomized phase III study of adjuvant oncophage versus observation in patients with
high risk of recurrence after surgical treatment for renal cell carcinoma
PI: E Goluboff, MD Contact Person: Pat Meade-D'Alisera
CNS
09/26/02
Brain & Nervous System
CPMC IRB# 7827
Chemotherapy of primary & metastatic CNS neoplasms: CNS penetration
PI: R Fine, MD Contact Person: Cara DeRosa
Brain & Nervous System
CAMP 013 IRB# 8017
Tandem thiotepa regimen for selected malignant gliomas: 1) recurrent glioblastoma multiforme (GBM),
2) recurrent anaplastic astrocytomas (AA), 3) recurrent oligodendrogliomas (O) or oligoastrocytomas
ependymomas and primitive neuroectodermal tumors (PNET) that have either progressed after primary
therapy or are refractory to standard chemotherapy
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Brain & Nervous System
CAMP 004A IRB# 8445
A phase II study of intensive chemotherapy (BET) for selected categories of malignant central
nervous system tumors, defined as: 1) recurrent anaplastic astrocytomas (AA), 2) primary or
recurrent oligodendrogliomas, 3) medulloblastomas and other primary neuroectodermal tumors (PNET),
4) germ cell tumors, 5) esthesioneuroblastomas, & 6) lymphomas
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Brain & Nervous System
CPMC IRB# 8622
Phase II study of temozolomide in the treatment of recurrent malignant gliomas
PI: C Balmaceda, MD Contact Person: Cara DeRosa
Brain & Nervous System
CPMC/IMMUNEX IRB# 9254
Double-blind, randomized trial comparing GM-CSF mouthwash to placebo in preventing/alleviating
chemotherapy induced mucositis in patients undergoing high dose chemotherapy and stem cell
transfusion or bone marrow transplantation
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
GI
09/26/02
Buccal Cavity and Pharynx
CPMC IRB# 7662
Effectiveness of a fluid-motion exercising device in treating jaw hypomobility during and after
radiation therapy to the head and neck
PI: R Wright, DDS Contact Person: Robert Wright, D.D.S.
Buccal Cavity and Pharynx
EISAI IRB# 13542
A phase II study of E7070 in patients with metastatic, recurrent, or refractory head and neck
squamous cell carcinoma (HNSCC)
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Esophagus
NCI IRB# 9032
The chemoprevention of Barrett's esophagus trial (CBET): a phase 2, multi-center, double-masked,
placebo-controlled study of the selective cyclooxgenase-2 inhibitor celecoxib
PI: C Lightdale, MD Contact Person: Kevin Bukowski R.N.
Esophagus
CPMC IRB# 13723
Barrett's esophagus ablation combined with celecoxib trial: a phase II single center randomized
parallel treatment design, double blind placebo-controlled study, comparing cyclooxygenase-2 (cox-2)
inhibitor, in combination with endoscopic thermal ablation of Barrrett's esophagus, to placebo and
thermal ablation
PI: C Lightdale, MD Contact Person: Peter Green, M.D.
Colon
SEARLE IRB# 9290
Prevention of sporadic colorectal adenomas with celecoxib
PI: C Lightdale, MD Contact Person: Kevin Bukowski R.N.
Colon
NCI IRB# 13649
A phase II trial of oral thalidomide as an adjuvant agent following metastasectomy in patients with
recurrent colorectal cancer
PI: J Chabot, MD Contact Person: Steven K. Libutti
Colon
CPMC IRB# 14029
A pilot study for the preoperative establishment of specific anti-tumor immune response in patients
with colorectal adenocarcinoma
PI: R Whelan, MD Contact Person: Zishan Asi
Colon
CPMC IRB# 14319
The perioperative non-specific up-regulation of immune function in patients with colorectal
adenocarcinoma
PI: R Whelan, MD Contact Person: Stephane Conte
Colon
AVENTIS PASTEUR IRB# 14534
A pilot phase II study of safety of immunogenicity of the ALVAC CEA B 7.1 vaccine administered with
chemotherapy, alone, or in combination with tetanus toxoid as compared to chemotherapy alone, in
patients with metastatic colorectal adenocarcinoma
PI: H Kaufman, MD Contact Person: Gail DeRaffele
Rectum
CPMC IRB# 13586
Prospective randomized trial comparing hand-assisted laparoscopic hybrid surgical techniques to the
standard hybrid method (combination of laparoscopic and open surgical methods) for the treatment of
distal colorectal tumors
PI: R Whelan, MD Contact Person: Zishan Asi
Rectum
NCI IRB# 13649
A phase II trial of oral thalidomide as an adjuvant agent following metastasectomy in patients with
recurrent colorectal cancer
PI: J Chabot, MD Contact Person: Steven K. Libutti
Rectum
AVENTIS PASTEUR IRB# 14534
A pilot phase II study of safety of immunogenicity of the ALVAC CEA B 7.1 vaccine administered with
chemotherapy, alone, or in combination with tetanus toxoid as compared to chemotherapy alone, in
patients with metastatic colorectal adenocarcinoma
PI: H Kaufman, MD Contact Person: Gail DeRaffele
Anus
CPMC IRB# 9979
A study to screen HIV positive males for anal squamous intraepithelial lesions and anal human
papillomavirus
PI: K Brudney, MD Contact Person: Timothy Wilkin
Liver
ZARIX INC. IRB# 13977
A phase III randomized controlled study comparing the survival of patients with unresectable
hepatocellular carcinoma (HCC) treated with thymitaq to patients treated with doxorubicin
PI: K Papadopoulos, MD Contact Person: Carey Field
Liver
CPMC IRB# 14082
Percutaneous treatment of liver tumors with acetic acid
PI: J Rundback, MD Contact Person: Leslie Schmidt, N.P.
Pancreas
CPMC IRB# 8544
Evaluation of intensive pancreatic proteolytic enzyme therapy with ancillary nutritional support in
the treatment of inoperable pancreatic adenocarcinoma
PI: J Chabot, MD Contact Person: Michelle Gabay, R.N.
Pancreas
CPMC IRB# 9155
Pilot for pancreatic carcinoma with gemcitabine, docetaxel and cisplatin
PI: W Sherman, MD Contact Person: Dr. William Sherman
Pancreas
ICPCI IRB# 9239
International cooperative pancreatic cyst (CPC) investigation
PI: P Stevens, MD Contact Person: Peter Stevens, M.D.
Lung
BRISTOL-MYERS SQUIBB IRB# 1181
A phase II study of novel epothilone BMS-247550 in patients with progressive small cell lung cancer
which was sensitive to first-line chemotherapy
PI: H Raftopoulos, MD Contact Person:
Lung
CPMC IRB# 9483
Evaluation of smoking cessation intervention in conjunction with CT screening
PI: S Sheinfeld Gorin, PhD Contact Person: Sherri Sheinfeld Gorin
Lung
CPMC/ELI LILLY IRB# 13871
A randomized phase II trial to outline the efficacy of gemcitabine containing regimens
(gemzar/carboplatin and gemzar/cisplatin) when used as preoperative chemotherapy in patients with
stage I and II non-small cell lung cancer (NSCLC)
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Lung
GLAXO SMITHKLINE IRB# 13920
An open-label, multicenter, randomized, phase III study comparing oral topotecan/cisplatin versus
etoposide/cisplatin as treatment for chemotherapy-naive patients with extensive disease small cell
lung cancer
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Lung
CPMC/AVENTIS IRB# 14000
A multicenter phase III study combining paclitaxel + carboplatin vs. single agent docetaxel in
patients with advanced non-small cell lung cancer
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Lung
ENZON INC. IRB# 14209
An evaluation of the efficacy and safety of peg-camptothecin in the treatment of relapsed stage IV
non-small cell lung cancer
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Lung
SWOG E5597 IRB# 14245
Phase III chemoprevention trial of selenium supplementation in persons with resected stage I
non-small cell lung cancer
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Lung
ISIS IRB# 14273
A phase II trial of ISIS-2503, an antisense inhibitor of H-ras, in combination with docetaxel for
patients with previously-treated advanced non-small cell lung cancer
PI: H Raftopoulos, MD Contact Person: Cara DeRosa
Soft Tissue
CELLPATH IRB# 9825
Phase II evaluation of CP4071 in previously treated advanced sarcomas
PI: R Taub, MD Contact Person: Anna Gong
Soft Tissue
CPMC/CELGENE/SCHERING PL IRB# 13887
Phase II study of low-dose interferon alfa-2b (Schering-Pough) plus thalidomide (Celgene) for
patients with resected high-risk soft tissue sarcoma
PI: R Taub, MD Contact Person: Rosalee
Liboro
Soft Tissue
NORTH AMERICAN SARCOMA IRB# 14060
Phase II trial of gleevec (formerly known as ST1571) in patients with soft tissue and bone sarcomas:
A multi-disciplinary trial of the North American Sarcoma Study Group of the Connective Tissue
Oncology Society
PI: M Keohan, MD Contact Person: Anna Gong
Soft Tissue
CPMC/PHARMACIA IRB# 14172
A phase II study of escalating doses of infusional single agent epirubicin hydrochloride (ellence)
for treatment of advanced soft tissue sarcoma, with correlative studies of cardiac toxicity, tissue
analysis for multidrug resistance (MDR), and evaluation of MDR by technetium-99m MIBI
PI: R Taub, MD Contact Person: Anna Gong
Soft Tissue
CPMC/SCHERING PLOUGH IRB# 14323
A phase II study of combination therapy of a protracted oral schedule of temozolomide and
thalidomide as first-line or subsequent therapy for patients with metastatic, locally advanced or
unresectable leiomyosarcoma
PI: R Taub, MD Contact Person: Rosalee
Liboro
Mesothelioma
ALFACELL IRB# 8035
Multicenter randomized comparative phase III trial of onconase plus doxorubicin vs. doxorubicin in
patients with malignant mesothelioma (part II)
PI: R Taub, MD Contact Person: Anna Gong
Mesothelioma
CPMC IRB# 13799
Phase II trial of combined resection, intraperitoneal chemotherapy, whole abdominal radiation in
peritoneal mesothelioma
PI: R Taub, MD Contact Person: Rosalee
Liboro
Mesothelioma
CPMC IRB# 14385
A phase II trial of perioperative gemcitabine and cisplatin chemotherapy and radiotherapy in
resected pleural mesothelioma
PI: R Taub, MD Contact Person: Rosalee
Liboro
Mesothelioma
CPMC/ASTRA ZENECA IRB# 14772
A phase II trial of ZD1839 (IRESSA), gemcitabine and cisplatin combined in chemotherapy in advanced
malignant mesothelioma
PI: M Keohan, MD Contact Person: Rosalee Liboro
Melanoma, skin
GENTA INC. IRB# 9928
Randomized study of dacarbazine versus dacarbazine plus G3139 (bcl-2 antisense oligonucleotide) in
patients with advanced malignant melanoma
PI: R Fine, MD Contact Person: Erin Sharpe
Melanoma, skin
CPMC/LUDWIG INST IRB# 13824
A phase I study of peptide based vaccine therapy in patients with high-risk or metastatic melanoma
PI: K Papadopoulos, MD Contact Person: Carey Field
Melanoma, skin
CPMC IRB# 14386
A phase II study of a 4-hour schedule of temozolomide in the treatment of patients with advanced
melanoma
PI: R Taub, MD Contact Person: Rosalee
Liboro
Melanoma, skin
NIH IRB# 14387
A phase I trial of intra-lesional rV-TRICOM in the treatment of malignant melanoma
PI: H Kaufman, MD Contact Person: Gail DeRaffele
Kaposis sarcoma
AMC 024 IRB# 13985
A phase I-II trial of BMS-275291 in patients with HIV-related Kaposis's sarcoma
PI: M Keohan, MD Contact Person: Rosalee Liboro
Kaposis sarcoma
AMC 027 IRB# 14559
A phase II trial of COL-3 in patients with HIV-related Kaposi's sacrcoma
PI: M Keohan, MD Contact Person: Rosalee Liboro
Other Skin
NCI IRB# 9923
A phase II, double-blind, placebo controlled clinical trial to asess celecoxib as a chemopreventive
agent inhibiting UV-induced erythema, and cutaneous carcinogenesis as assessed through surrogate
biological markers in biopsied skin after exposure of skin in normal volunteers ages 20-60 years old
with Fitzpatrick type I, II, III and IV skin to UV radiation from artificial light sources
PI: D Bickers, MD Contact Person: Cathy Donovan
Other Skin
CPMC IRB# 9945
A phase III randomized, double-blind, placebo-controlled clinical trial of celecoxib in subjects
with basal cell nevus syndrome
PI: D Bickers, MD Contact Person: Cathy Donovan
Thyroid
AMGEN IRB# 14234
An assessment of the calcimimetic agent 073 for the treatment of subjects with parathyroid carcinoma
PI: S Silverberg, MD Contact Person: Mishaela Rubin, M.D.
Non-Hodgkins Lymphoma
CAMP 002 IRB# 6706
Phase II study of high dose chemotherapy (CBE) followed by hematopoietic progenitor cell support in
patients with refractory or relapsed Hodgkin's or non-Hodgkin's lymphoma
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CAMP 006 IRB# 7982
Tandem high dose chemotherapy and autologous blood stem cell transplantation for poor risk lymphoma
PI: D Savage, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CAMP 025 IRB# 8462
Non-ablative chemotherapeutic conditioning for allogeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CPMC/IMMUNEX IRB# 9254
Double-blind, randomized trial comparing GM-CSF mouthwash to placebo in preventing/alleviating
chemotherapy induced mucositis in patients undergoing high dose chemotherapy and stem cell
transfusion or bone marrow transplantation
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
INEX IRB# 9661
Pivotal phase II multicenter study of vincristine sulfate liposomes injection in diffuse large
B-cell non-Hodgkin's lymphoma at second or later relapse
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CPMC IRB# 9785
Gemcitabine for resistant or relapsed lymphoma or chronic lymphocytic leukemia
PI: D Savage, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
AMC 029/IDEC IRB# 13998
A phase I trial of combination bryostatin-1 and vincristine in HIV-related B-cell neoplasms
PI: M Keohan, MD Contact Person: Rosalee Liboro
Non-Hodgkins Lymphoma
CPMC/BERLEX IRB# 14569
Combined rituximab and fludarabine for low-grade lymphoma and chronic lymphocytic leukemia
PI: D Savage, MD Contact Person: Erin Sharpe
Hodgkins Lymphoma
CAMP 002 IRB# 6706
Phase II study of high dose chemotherapy (CBE) followed by hematopoietic progenitor cell support in
patients with refractory or relapsed Hodgkin's or non-Hodgkin's lymphoma
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Hodgkins Lymphoma
CAMP 006 IRB# 7982
Tandem high dose chemotherapy and autologous blood stem cell transplantation for poor risk lymphoma
PI: D Savage, MD Contact Person: Erin Sharpe
Hodgkins Lymphoma
SWOG E2496 IRB# 9465
Randomized phase III trial of ABVD vs. Stanford V +/- radiation therapy in locally extensive and
advanced stage Hodgkin's disease with 0-2 risk factors
PI: D Savage, MD Contact Person: Yvette Ortiz-Pride
Hodgkins Lymphoma
CPMC IRB# 9785
Gemcitabine for resistant or relapsed lymphoma or chronic lymphocytic leukemia
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Myeloma
CAMP 009 IRB# 7328
Phase II study of high dose chemotherapy followed by autologous hematopoietic stem cell support in
patients with multiple myeloma
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Myeloma
CAMP 009A IRB# 9041
Study of high dose chemotherapy followed by autologous hematopoietic stem cell support in patients
with primary light chain amyloidosis
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Myeloma
CPMC/ CELGENE/AMGEN IRB# 9770
Cyclophosphamide and thalidomide in relapsed or refractory multiple myeloma
PI: D Savage, MD Contact Person: Kate Keenan, R.N.
Multiple Myeloma
GENTA INCORPORATED IRB# 13785
Randomized phase III study of dexamethasone with or without genasense (bcl-2 antisense
oligonucleocide) in patients with relapsed or refractory multiple myeloma
PI: G Nichols, MD Contact Person: Kate Keenan, R.N.
Multiple Myeloma
CPMC IRB# 13929
Cyclophosphamide and thalidomide for untreated multiple myeloma
PI: D Savage, MD Contact Person: Erin Sharpe
Lymphoid Leukemia
ILEX IRB# 8610
Phase II trial of aminopterin in adults and children with refractory acute leukemia
PI: K Kelly, MD Contact Person: Margie
Negron
Lymphoid Leukemia
CAMP 027 IRB# 8872
High dose chemotherapy and autologous peripheral blood stem rescue for high risk acute leukemia
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Lymphoid Leukemia
CPMC IRB# 9785
Gemcitabine for resistant or relapsed lymphoma or chronic lymphocytic leukemia
PI: D Savage, MD Contact Person: Erin Sharpe
Lymphoid Leukemia
CPMC/BERLEX IRB# 14569
Combined rituximab and fludarabine for low-grade lymphoma and chronic lymphocytic leukemia
PI: D Savage, MD Contact Person: Erin Sharpe
Myeloid Leukemia
ILEX IRB# 8610
Phase II trial of aminopterin in adults and children with refractory acute leukemia
PI: K Kelly, MD Contact Person: Margie
Negron
Myeloid Leukemia
CAMP 027 IRB# 8872
High dose chemotherapy and autologous peripheral blood stem rescue for high risk acute leukemia
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Myeloid Leukemia
CPMC/WYETH/IMMUNEX IRB# 13787
A combination chemotherapy trial of gemtuzumab ogozamicin with escalating dose mitoxantrone in
patients with relapsed/refractory acute myelogenous leukemia, CML myeloblastic crisis and high risk
MDS
PI: G Nichols, MD Contact Person: Kate Keenan, R.N.
Myeloid Leukemia
WYETH-AYERST IRB# 14145
Prospective observational study of mylotarg (gemtuzumab ozogamicin) in usual care
PI: G Nichols, MD Contact Person: Kate Keenan, R.N.
Leukemia, not otherwise s
CAMP 012 IRB# 475
Standard chemotherapy and radiotherapy before allogeneic and syngeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 016 IRB# 7651
The use of peripheral blood stem cells for allogeneic transplantation in patients with advanced
hematological malignancies at increased risk of relapse or transplant-related mortality
PI: D Savage, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 021 IRB# 7934
Transplantation using umbilical cord and placental blood
PI: D Savage, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 025 IRB# 8462
Non-ablative chemotherapeutic conditioning for allogeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 012 IRB# 475
Standard chemotherapy and radiotherapy before allogeneic and syngeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 016 IRB# 7651
The use of peripheral blood stem cells for allogeneic transplantation in patients with advanced
hematological malignancies at increased risk of relapse or transplant-related mortality
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 021 IRB# 7934
Transplantation using umbilical cord and placental blood
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 009A IRB# 9041
Study of high dose chemotherapy followed by autologous hematopoietic stem cell support in patients
with primary light chain amyloidosis
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 012 IRB# 475
Standard chemotherapy and radiotherapy before allogeneic and syngeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CPMC IRB# 6435
Cryopreservation of human stem cells with hydroxyethyl starch and dimethyl sulfoxide
PI: D Skerrett, MD Contact Person: Donna Skerrett M.D.
Multiple Sites/Ill-define
CAMP 016 IRB# 7651
The use of peripheral blood stem cells for allogeneic transplantation in patients with advanced
hematological malignancies at increased risk of relapse or transplant-related mortality
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 019 IRB# 7661
Study of the use of CD34+ cells, isolated from bone marrow and/or mobilized peripheral blood
progenitor cell (PBPC) collections using the nexell isolex 300i system or the miltenyi biotec
clinimacs system, for the hematologic rescue of patients with breast cancer, neuroblastoma, sarcoma,
myeloma and lymphoma treated with high-dose chemotherapy
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CPMC IRB# 7701
Peripheral stem cell mobilization and harvest for allogeneic transplant
PI: M Pessin, MD Contact Person: Donna Skerrett M.D.
Multiple Sites/Ill-define
CAMP 021 IRB# 7934
Transplantation using umbilical cord and placental blood
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 025 IRB# 8462
Non-ablative chemotherapeutic conditioning for allogeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CPMC IRB# 8747
Non-subjective assessment of lens opacities after bone marrow transplantation (BMT)
PI: A Junk, MD Contact Person: Anna Junk
Multiple Sites/Ill-define
CPMC/IMMUNEX IRB# 9254
Double-blind, randomized trial comparing GM-CSF mouthwash to placebo in preventing/alleviating
chemotherapy induced mucositis in patients undergoing high dose chemotherapy and stem cell
transfusion or bone marrow transplantation
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
SANOFI SYNTHELA IRB# 9651
Compassionate use of urate oxidase (SR29142) for prevention or treatment of hyperuricemia at
multiple centers in the United States and Canada
PI: M Cairo, MD Contact Person: Lauren Harrison
Multiple Sites/Ill-define
PHARMACIA UPJOHN IRB# 9656
A phase I evaluation of weekly intravenous estramustine phosphate in combination with docetaxel in
men and women with solid tumors
PI: D Petrylak, MD Contact Person: Jill
Muir
Multiple Sites/Ill-define
CPMC IRB# 9953
A phase III randomized study of procrit (epoetin alfa) treatment administered to patients undergoing
high dose chemotherapy with stem cell support
PI: L Vahdat, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
ELI LILLY IRB# 9971
A phase I clinical and pharmacokinetic evaluation of LY293111 in combination with gemcitabine in
patients with solid tumors
PI: D Petrylak, MD Contact Person: Jill
Muir
Multiple Sites/Ill-define
LUDWIG INST. IRB# 13578
A pilot study of NY-ESO-I peptide immunization of patients with cancer expressing NY-ESO-I/LAGE
antigen
PI: K Papadopoulos, MD Contact Person: Carey Field
Multiple Sites/Ill-define
CPMC IRB# 13623
Neutrophil transfusions from donors stimulated with granulocyte-colony stimulating factor and
dexamethozone: effect on donor tolerance, neutrophil function, and patient response
PI: D Skerrett, MD Contact Person: David S. Bernstein
Multiple Sites/Ill-define
AMCELL IRB# 13862
A multi-center feasibility study evaluating haploidentical allogeneic transplantation in patients
with advanced hematological malignant diseases and non-malignant disorders
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CPMC IRB# 14536
A phase I study of a novel chemotherapeutic regimen:topotecan , ifosfoamide and carboplatin (TIC) in
children and young adults with solid tumors
PI: M Cairo, MD Contact Person: Lauren Harrison,RN
Multiple Sites/Ill-define
CPMC/AMGEN IRB# 14541
Assessing the burden of chemotherapy side effects in patients who have experienced side effects and
nurses who care for this patient population
PI: A Nirenberg, MD Contact Person: Sarah Hopkins
Adj. Breast
CAMP 008 IRB# 7480
A randomized trial of cyclosporine alpha and interferon gamma versus low-dose IL-2 to eliminate
minimal residual breast cancer in patients undergoing high dose chemotherapy in complete remission
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Adj. Breast
CAMP 014 IRB# 7608
Phase III study of high dose chemotherapy followed by autologous hematopoietic stem cell support and
immunomodulation in women with high risk stage II and stage III breast cancer
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Loc. Adv. Breast
CAMP 014 IRB# 7608
Phase III study of high dose chemotherapy followed by autologous hematopoietic stem cell support and
immunomodulation in women with high risk stage II and stage III breast cancer
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Ovary
CAMP20/BMS/SKB IRB# 7866
PhaseI/II study of tandem cycles of high dose chemotherapy followed by autologous hematopoietic stem
cell support in women with persistent or recurrent advanced (stage III or IV) epithelial ovarian
cancer
PI: A Tiersten, MD Contact Person: Erin Sharpe
Brain & Nervous System
CAMP 004A IRB# 8445
A phase II study of intensive chemotherapy (BET) for selected categories of malignant central
nervous system tumors, defined as: 1) recurrent anaplastic astrocytomas (AA), 2) primary or
recurrent oligodendrogliomas, 3) medulloblastomas and other primary neuroectodermal tumors (PNET),
4) germ cell tumors, 5) esthesioneuroblastomas, & 6) lymphomas
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Brain & Nervous System
CPMC/IMMUNEX IRB# 9254
Double-blind, randomized trial comparing GM-CSF mouthwash to placebo in preventing/alleviating
chemotherapy induced mucositis in patients undergoing high dose chemotherapy and stem cell
transfusion or bone marrow transplantation
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CAMP 002 IRB# 6706
Phase II study of high dose chemotherapy (CBE) followed by hematopoietic progenitor cell support in
patients with refractory or relapsed Hodgkin's or non-Hodgkin's lymphoma
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CAMP 006 IRB# 7982
Tandem high dose chemotherapy and autologous blood stem cell transplantation for poor risk lymphoma
PI: D Savage, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CAMP 025 IRB# 8462
Non-ablative chemotherapeutic conditioning for allogeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Non-Hodgkins Lymphoma
CPMC/IMMUNEX IRB# 9254
Double-blind, randomized trial comparing GM-CSF mouthwash to placebo in preventing/alleviating
chemotherapy induced mucositis in patients undergoing high dose chemotherapy and stem cell
transfusion or bone marrow transplantation
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Hodgkins Lymphoma
CAMP 002 IRB# 6706
Phase II study of high dose chemotherapy (CBE) followed by hematopoietic progenitor cell support in
patients with refractory or relapsed Hodgkin's or non-Hodgkin's lymphoma
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Hodgkins Lymphoma
CAMP 006 IRB# 7982
Tandem high dose chemotherapy and autologous blood stem cell transplantation for poor risk lymphoma
PI: D Savage, MD Contact Person: Erin Sharpe
Lymphoid Leukemia
CAMP 027 IRB# 8872
High dose chemotherapy and autologous peripheral blood stem rescue for high risk acute leukemia
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Myeloid Leukemia
CAMP 027 IRB# 8872
High dose chemotherapy and autologous peripheral blood stem rescue for high risk acute leukemia
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 012 IRB# 475
Standard chemotherapy and radiotherapy before allogeneic and syngeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 016 IRB# 7651
The use of peripheral blood stem cells for allogeneic transplantation in patients with advanced
hematological malignancies at increased risk of relapse or transplant-related mortality
PI: D Savage, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 021 IRB# 7934
Transplantation using umbilical cord and placental blood
PI: D Savage, MD Contact Person: Erin Sharpe
Leukemia, not otherwise s
CAMP 025 IRB# 8462
Non-ablative chemotherapeutic conditioning for allogeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 012 IRB# 475
Standard chemotherapy and radiotherapy before allogeneic and syngeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 016 IRB# 7651
The use of peripheral blood stem cells for allogeneic transplantation in patients with advanced
hematological malignancies at increased risk of relapse or transplant-related mortality
PI: D Savage, MD Contact Person: Erin Sharpe
Other Hematopoietic
CAMP 021 IRB# 7934
Transplantation using umbilical cord and placental blood
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 012 IRB# 475
Standard chemotherapy and radiotherapy before allogeneic and syngeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 016 IRB# 7651
The use of peripheral blood stem cells for allogeneic transplantation in patients with advanced
hematological malignancies at increased risk of relapse or transplant-related mortality
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 019 IRB# 7661
Study of the use of CD34+ cells, isolated from bone marrow and/or mobilized peripheral blood
progenitor cell (PBPC) collections using the nexell isolex 300i system or the miltenyi biotec
clinimacs system, for the hematologic rescue of patients with breast cancer, neuroblastoma, sarcoma,
myeloma and lymphoma treated with high-dose chemotherapy
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 021 IRB# 7934
Transplantation using umbilical cord and placental blood
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CAMP 025 IRB# 8462
Non-ablative chemotherapeutic conditioning for allogeneic stem cell transplantation
PI: D Savage, MD Contact Person: Erin Sharpe
Multiple Sites/Ill-define
CPMC IRB# 8747
Non-subjective assessment of lens opacities after bone marrow transplantation (BMT)
PI: A Junk, MD Contact Person: Anna Junk
Multiple Sites/Ill-define
CPMC/IMMUNEX IRB# 9254
Double-blind, randomized trial comparing GM-CSF mouthwash to placebo in preventing/alleviating
chemotherapy induced mucositis in patients undergoing high dose chemotherapy and stem cell
transfusion or bone marrow transplantation
PI: C Hesdorffer, MD Contact Person: Erin Sharpe
Total Protocols: 152