Clinical Research Protocols:
Clinical Research Protocols in Malignant Melanoma
Compiled by Margaret Gross-King, RN, MS, OCN
Clinical Research Manager, H. Lee Moffitt Cancer Center & Research Institute
For more information on
these protocols, please call PDQ, a service of the National Cancer Institute,
at 1-800-4-CANCER.
Adjuvant Trials
NCI High-Priority Clinical
Trial EST-1690 Phase III Study of Adjuvant Postoperative Interferon Alpha
in Melanoma Patients at High Risk for Recurrence: High Dose for 1 Year vs Chronic
Low Dose vs No Treatment (Summary Last Modified 07/94)
Chairman: Robert L. Comis,
Thomas Jefferson University Hospital, Philadelphia, Pa. Lead Organization: Eastern
Cooperative Oncology Group. Acceptable age range: physiologic 18-70
ARG-CO/BR-1 Phase
III Postsurgical Maintenance Immunotherapy With Corynebacterium Granulosum p40
for Patients With Colon and Breast Cancer and Melanoma Residual Following Surgery
(Summary Last Modified 04/93)
Chairman: Hugo Omar De Carli,
Centro Oncologico de Excelencia, Buenos Aires, Argentina. Lead Organization:
Centro Oncologico de Excelencia. Acceptable age range: 20 to 80
EORTC-18871 Phase
III Randomized Study of Adjuvant Treatment With IFN-A vs IFN-G vs No Adjuvant
Therapy in Patients With Resected High-Risk Stage I/IIB Malignant Melanoma (Summary
Last Modified 06/88)
Chairman: U. R. Kleeberg,
Haematologisch-Onkologische Praxis Altona, Hamburg, Germany. Lead Organization:
EORTC Melanoma Cooperative Group. Acceptable age range: any age
EORTC-DKG-80-1 Phase
III Randomized Trial of Adjuvant Treatment With IFN-A vs IFN-G vs Mistletoe
Extract (Icador M) vs No Further Treatment Following Curative Resection of High-Risk
Stage I/IIB Malignant Melanoma (Summary Last Modified 11/93)
Chairman: U. R. Kleeberg,
Haematologisch-Onkologische Praxis Altona, Hamburg, Germany. Lead Organization:
EORTC Melanoma Cooperative Group. Acceptable age range: 18 to 80
NCCTG-897051 Phase
III Randomized Double-Blind Study of Postoperative Clinical Adjuvant Therapy
With MEG vs Placebo in Patients With Poor-Prognosis Stage I/II Malignant Melanoma
(Summary Last Modified 03/94)
Chairman: Robert J. Dalton,
Duluth Clinic, Duluth, Minn. Lead Organization: North Central Cancer Treatment
Group. Acceptable age range: 18 and over
RTOG-9302 Phase III
Randomized Study of Postoperative Adjuvant Radiotherapy in Patients With Cutaneous
Melanoma of the Head and Neck (Summary Last Modified 12/93)
Chairman: Robert M. Byers,
M.D. Anderson Cancer Center, University of Texas, Houston, Tex. Lead Organization:
Radiation Therapy Oncology Group. Acceptable age range: 18 and over
SWOG-9035 Phase III
Randomized Trial of Adjuvant Immunotherapy With an Allogeneic Melanoma Vaccine
for Patients With Intermediate-Thickness, Node- Negative Malignant Melanoma
(Summary Last Modified 03/95)
Chairman: Vernon K. Sondak,
Taubman Medical Center, University of Michigan, Ann Arbor, Mich. Lead Organization:
Southwest Oncology Group. Acceptable age range: 18 and over
Locally Advanced Disease
Trials
NCI-92-C-0105E, NCI-T91-0238N
Phase III Randomized Study of Hyperthermic Isolated Limb Perfusion With L-PAM
vs L-PAM/TNF/IFN-G in Patients With Stage IIIA/IIIB Malignant Melanoma Confined
to an Extremity (Summary Last Modified 10/94)
Chairman: Douglas L. Fraser,
Surgery Branch, COP, DCT, National Cancer Institute, Bethesda, Md. Lead Organization:
Clinical Oncology Program. Acceptable age range: 18 and over
MSKCC-94041, NCI-V94-04712
Phase II Pilot Study of Vaccination With GN2-KLH Plus QS211 in Stage III/IV
Melanoma (Summary Last Modified 06/95)
Chairman: Paul B. Chapman,
Memorial Sloan-Kettering Cancer Center, New York, NY. Lead Organization: Memorial
Sloan-Kettering Cancer Center. Acceptable age range: no age specified
MSKCC-94029, NCI-V94-0467
Phase I/II Study of Vaccination With Tyrosinase Peptides or Proteins or Tyrosinase-KLH
Conjugate Plus QS-21 in High-Risk Stage III/IV Melanoma (Summary Last Modified
06/95)
Chairman: Alan N. Houghton,
Jr., Memorial Sloan-Kettering Cancer Center, New York, NY. Lead Organization:
Memorial Sloan-Kettering Cancer Center. Acceptable age range: no age specified
MSKCC-94078, NCI-V-94-0538
Phase I/II Pilot Study of Anti-Idiotypic MOAD BEC2 Conjugated to KLH Plus BCG
as Adjuvant in Completely Resected Melanoma (Summary Last Modified 03/95)
Chairman: Paul B. Chapman,
Memorial Sloan-Kettering Cancer Center, New York, NY. Lead Organization: Memorial
Sloan-Kettering Cancer Center. Acceptable age range: 18 and over
METASTATIC DISEASE TRIALS
MSKCC-91140, NCI-V92-0030,
UPCC-2691 Phase III Randomized Study of CDDP/DTIC/BCNU/TMX vs DTIC Alone
in Patients With Advanced Melanoma (Summary Last Modified 06/95)
Chairman: Michael L. Meyers,
Memorial Sloan-Kettering Cancer Center, New York, NY. Lead Organization: Memorial
Sloan-Kettering Cancer Center. Acceptable age range: 18 and over
MDA-DM-88126, NCI-T88-0223D
Phase III Randomized Comparison of CVD (CDDP/VBL/DTIC) vs DTIC Alone in Patients
With Metastatic Melanoma (Last Modified 09/93)
Chairman: Sewa Singh Legha,
M.D. Anderson Cancer Center, University of Texas, Houston, Tex. Lead Organization:
M.D. Anderson Cancer Center, University of Texas. Acceptable age range: 16 to
80
NCCTG-907051 Phase
III Randomized Study of CDDP/BCNU/DTIC With vs Without TMX in Patients With
Advanced Malignant Melanoma (Summary Last Modified 09/94)
Chairman: Robert J. Dalton,
Duluth Clinic, Duluth, Minn. Lead Organization: North Central Cancer Treatment
Group. Acceptable age range: 18 and over
NCI-93-C-0187D, NCI-T93-0091N
Phase II Study of TMX/CDDP/DTIC/IFN-A Followed by TIL/IL-2 in Patients With
Metastatic Malignant Melanoma Who Have Not Previously Received CDDP/DTIC, IFN-A
or IL-2 Systemically (Summary Last Modified 06/95)
Chairman: Steven A. Rosenberg,
Surgery Branch, COP, DCT, National Cancer Institute, Bethesda, Md. Lead Organization:
Clinical Oncology Program. Acceptable age range: 18 and over
SWOG-9223 Phase II
Study of IFN-A/TRA in Patients With Stage IV Melanoma (Summary Last Modified
05/94)
Chairman: Frank L. Meyskens,
Jr., University of California Irvine Clinical Cancer Center, Orange, Calif.
Lead Organization: Southwest Oncology Group. Acceptable age range: adult
SWOG-9350 Phase II
Pilot Study of IFN-A With DTIC/CDDP/TMX in Disseminated Malignant Melanoma (Summary
Last Modified 04/95)
Chairman: Kim Allyson Margolin,
City of Hope National Medical Center, Duarte, Calif. Lead Organization: Southwest
Oncology Group. Acceptable age range: 18 and over
UPCC-1691, NCI-T91-0262D
Phase II Trial of TRA in Patients With Metastatic Melanomas (Summary Last Modified
06/92)
Chairman: Lynn Mara Schuchter,
University of Pennsylvania Cancer Center, Philadelphia, Pa. Lead Organization:
University of Pennsylvania Cancer Center. Acceptable age range: 18 and over
NBSG-9209, NCI-V92-0149
Phase II Study of IL-2 in Patients With Metastatic Renal Cell Carcinoma and
Melanoma (Summary Last Modified 06/95)
Chairman: Robert O. Dillman,
Hoag Memorial Hospital Presbyterian, Hoag Cancer Center, Newport Beach, Calif.
Lead Organization: National Biotherapy Study Group. Acceptable age range: 18
and over
NBSG-9411, NCI-V94-0574
Phase II Study of BCNU/DTIC/CDDP/IFN-A/IL-2/TMX Followed by IFN/A or IL-2 for
Advanced Melanoma (Summary Last Modified 04/95)
Chairman: Richard S. Schulof,
Presbyterian-St. Luke's Medical Center, Denver, Colo. Lead Organization: National
Biotherapy Study Group. Acceptable age range: 18 and over
MDA-DM-88128, NCI-T88-0224C
Phase II Combination Chemotherapy With CCNU/TG/PCB/DBD Followed by 5-FU/HU for
Brain Metastases From Adenocarcinomas of the Breast and Colon, Melanoma, and
Germ Cell Tumors (Summary Last Modified 01/95)
Chairman: Victor Alan Levin,
M.D. Anderson Cancer Center, University of Texas, Houston, Tex. Lead Organization:
M.D. Anderson Cancer Center, University of Texas. Acceptable age range: 16 and
over
AECM-9302040, NCI-T92-0214D
Phase II Study of Taxotere in Patients With Advanced Melanoma Previously Untreated
With Cytotoxic Chemotherapy (Summary Last Modified 06/93)
Chairman: Avi Israel Einzig,
Jack D. Weiler Hospital of the Albert Einstein College of Medicine, Bronx, NY.
Lead Organization: Albert Einstein Cancer Research Center. Acceptable age range:
18 and over
BRMP-9001C, MCI-T89-0239N,
NCI-90-C-83C Phase II Evaluation of IL-1A, Indomethacin and VP-16 in Patients
With Metastatic Malignant Melanoma (Summary Last Modified 06/93)
Chairman: Langdon L. Miller,
Biological Response Modifiers Program, National Cancer Institute, Frederick,
Md. Lead Organization: Biological Response Modifiers Program. Acceptable age
range: 18 and over
NCI-93-C-0189F, NCI-T93-0090N
Phase II Randomized Study of TMX/CDDP/DTIC With or Without IFN-A/IL-2 in Patients
With Metastatic Melanoma (Summary Last Modified 06/95)
Chairman: Steven A. Rosenberg,
Surgery Branch, COP, DCT, National Cancer Institute, Bethesda, Md. Lead Organization:
Clinical Oncology Program. Acceptable age range: 18 and over
STLMC-BRM-93004, NCI-V-93-0295
Phase II Study of Immunomodulation Using Indomethacin With TIL/IL-2/CTX or With
LAK/IL-2 in Patients With Advanced Melanoma (Summary Last Modified 09/94)
Chairman: John P. Hanson,
Jr., St. Luke's Medical Center, Milwaukee, Wisc. Lead Organization: St. Luke's
Medical Center. Acceptable age range: over 16
STLMC-BRM-93005, NCI-V94-0505
Phase II Study of TMX/CDDP/DTIC/IFN-A Followed by TIL/IL-2 for Advanced Melanoma
(Summary Last Modified 03/95)
Chairman: John P. Hanson,
Jr., St. Luke's Medical Center, Milwaukee, Wisc. Lead Organization: St. Luke's
Medical Center. Acceptable age range: over 16
PCI-9281, NCI-V93-0230
Phase II Study of the Antitumor Efficacy of In Vitro- Sensitized Lymphocytes
Harvested from Tumor Vaccine-Draining Lymph Nodes Plus IL-2 in Patients With
Metastatic or Recurrent Melanoma or Renal Cell Carcinoma (Summary Last Modified
07/95)
Chairman: Theodore F. Logan,
University of Pittsburgh School of Medicine, Pittsburgh, Pa. Lead Organization:
University of Pittsburgh Cancer Institute. Acceptable age range: 18 and over
BRMP-9406, NCI-T94-0091N
Phase II Study of Phenylacetate by 6-Day Continuous Infusion for Metastatic
Melanoma (Summary Last Modified 01/95)
Chairman: Barry L. Gause,
Outpatient Clinic, BRMP, National Cancer Institute, Frederick, Md. Lead Organization:
Biological Response Modifiers Program. Acceptable age range: 18 and over
DMS-9217, NCI-V93-0025
Phase II Study of IFN-A/Hydralazine in Patients With Metastatic Renal Cell Carcinoma
or Metastatic Melanoma (Summary Last Modified 04/93)
Chairman: Marc Stuart Ernstoff,
Norris Cotton Cancer Center, Dartmouth- Hitchcock Medical Center, Lebanon, NH.
Lead Organization: Norris Cotton Cancer Center. Acceptable age range: over 18
ICC-89M1, NCI-T89-0037D
Phase II Study of 6-Thioguanine in Patients With Metastatic Melanoma (Summary
Last Modified 01/91)
Chairman: Jamie Hayden Von
Roenn, Northwestern University Oncology Center, Chicago, Ill. Lead Organization:
Illinois Cancer Center Closeout Project. Acceptable age range: any age
KUMC-5699-93, NCI-V94-0426
Phase II Study of Autologous Tumor Cell Vaccine Therapy Followed by Adoptive
Immunotherapy With Peripheral Blood Mononuclear Cells/IL-2 for Stage IV Melanoma
(Summary Last Modified 07/94)
Chairman: Gary W. Wood,
University of Kansas Medical Center, Kansas City, Kan. Lead Organization: University
of Kansas Medical Center. Acceptable age range: 18 and over
MCGILL-T93-0176, NCI-T93-0176O
Phase II Study of BSO/L-PAM in Patients With Metastatic Cutaneous Melanoma (Summary
Last Modified 07/94)
Chairman: Gerald Batist,
Jewish General Hospital, Montreal, Quebec, Canada. Lead Organization: McGill
University Department of Oncology. Acceptable age range: 18 and over
NCI-93-C-0189F, NCI-T93-0090N
Phase II Randomized Study of TMX/CDDP/DTIC With or Without IFN-A/IL-2 in Patients
With Metastatic Melanoma (Summary Last Modified 05/95)
Chairman: Steven A. Rosenberg,
Surgery Branch, COP, DCT, National Cancer Institute, Bethesda, Md. Lead Organization:
Clinical Oncology Program. Acceptable age range: 18 and over
YALE-HIC-7679, NCI-V94-0554
Phase II Study of Immune Stimulation by Infusion of Autologous Buffy Coat Cells
Treated With Methoxsalen and Ultraviolet Radiation in Patients With Metastatic
Melanoma, Renal Cell Carcinoma or Nonsmall Cell Lung Cancer (Summary Last Modified
04/95)
Chairman: John R. Murren,
Yale Comprehensive Cancer Center, New Haven, Conn. Lead Organization: Yale Comprehensive
Cancer Center. Acceptable age range: over 18
BRMP-9207, NCI-T94-0083N
Phase IB Study of Anti-CD3 MOAB OKT 3 Plus IL-2 for Metastatic Melanoma and
Other Malignancies (Summary Last Modified 03/95)
Chairman: Barry L. Gause,
Outpatient Clinic, BRMP, National Cancer Institute, Frederick, Md. Lead Organization:
Biological Response Modifiers Program. Acceptable age range: 18 and over
NYU-9201, NCI-B92-0015
Phase IB Study of IL-1A/CDDP in Patients With Metastatic Melanoma (Summary Last
Modified 05/94)
Chairman: Abraham Chachoua,
Kaplan Comprehensive Cancer Center, New York, NY. Lead Organization: Kaplan
Comprehensive Cancer Center. Acceptable age range: 18 and over
WCCC-CO-9296, NCI-T92-0206D
Phase I Study of Intravenous BSO, Administered as an Initial Bolus Followed
by a 24- to 48-Hour Continuous Infusion, Given With Intravenous L-PAM in Patients
With Advanced Malignancies Including Melanoma and Ovarian Epithelial Cancer
(Summary Last Modified 12/93)
Chairman: Howard H. Bailey,
Wisconsin Comprehensive Cancer Center, Madison, Wisc. Lead Organization: Wisconsin
Comprehensive Cancer Center. Acceptable age range: 18 and over
NCI-95-C-0136 Phase
I Study of NG-Monomethyl-L-Arginine for IL-2-Induced Hypotension in Patients
With Metastatic Melanoma (Summary Last Modified 08/95)
Chairman: David R. Parkinson,
Cancer Therapy Evaluation Program, DCT, National Cancer Institute, Bethesda,
Md. Lead Organization: Clinical Oncology Program. Acceptable age range: 18 and
over
LAC-USC-10M951, NCI-T94-0226O
Phase I Study of Immunization With a MAGE-3 Vaccine Consisting of Cytolytic
and Helper T Cell Peptides in HLA-A1-Positive Patients With Resectable Stage
III/IV Melanoma (Summary Last Modified 07/95)
Chairman: Jeffrey S. Weber,
USC/Norriss Comprehensive Cancer Center, University of California School of
Medicine, Los Angeles, Calif. Lead Organization: USC/Norriss Comprehensive Cancer
Center. Acceptable age range: 18 and over
MDA-DM-90102, NCI-B93-0009
Phase I Study of Chimeric MOAB 14.18 Plus GM-CSF for Metastatic Melanoma (Summary
Last Modified 05/95)
Chairman: J. Lee Murray,
M.D. Anderson Cancer Center, University of Texas, Houston, Tex. Lead Organization:
M.D. Anderson Cancer Center, University of Texas. Acceptable age range: 18 to
physiologic 70
Legend for Abbreviations:
AECM = Albert Einstein College
of Medicine
ARG-CO = Centro Oncologico de Excelencia, Argentina
BRMP = Biological Response Modifiers Program
DMS = Dartmouth-Hitchcock Medical Center
EORTC = European Organization for Research on Treatment of Cancer
EST = Eastern Cooperative Oncology Group
ICC = Illinois Cancer Center
KUMC = University of Kansas Medical Center
LAC-USC = University of Southern California-Norris Comprehensive Cancer Center
MCGILL = McGill University Department of Oncology
MDA = M.D. Anderson Cancer Center
MSKCC = Memorial Sloan-Kettering Cancer Center
NBSG = National Biotherapy Study Group
NCCTG = North Central Cancer Treatment Group
NCI = National Cancer Institute
NYU = Kaplan Comprehensive Cancer Center
PCI = University of Pittsburgh Cancer Institute
RTOG = Radiation Therapy Oncology Group
STLMC = St. Luke's Medical Center
SWOG = Southwest Oncology Group
UPCC = University of Pennsylvania Cancer Center
WCCC = Wisconsin Comprehensive Cancer Center
YALE = Yale Comprehensive Cancer Center
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