Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005961 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than once chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of O6-benzylguanine and carmustine in treating patients who have unresectable locally recurrent or metastatic melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: O6-benzylguanine Drug: carmustine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (chemotherapy failure vs chemotherapy naive).
Patients receive O6-benzylguanine IV over 1 hour, followed 1 hour later by carmustine IV over 1 hour on day 1. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Patients with disease progression are followed every 6 months. All other patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 24-41 patients will be accrued for the chemotherapy failure stratum and a total of 18-35 patients will be accrued for the chemotherapy naive stratum of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven unresectable locally recurrent or metastatic melanoma
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
Lutheran General Cancer Care Center | |
Park Ridge, Illinois, United States, 60068 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
University of Illinois at Chicago Health Sciences Center | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Incorporated | |
Fort Wayne, Indiana, United States, 46885-5099 | |
Michiana Hematology/Oncology P.C. | |
South Bend, Indiana, United States, 46617 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Mercy Ireland Cancer Center | |
Canton, Ohio, United States, 44708 |
Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
Study ID Numbers: | CDR0000067943, UCCRC-10325, CWRU-1699, NCI-T99-0111 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005961 |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carmustine Neuroepithelioma |
O(6)-benzylguanine Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Neoplasms, Nerve Tissue |
Enzyme Inhibitors Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |