A Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU (Carmustine) in Patients With Metatstatic Melanoma
OBJECTIVES:
I. Determine the objective clinical response rate and duration of response in patients with
unresectable locally recurrent or metastatic melanoma treated with O6-benzylguanine and
carmustine.
II. Compare the toxicities of this regimen in patients with no prior chemotherapy vs prior
chemotherapy failure.
III. Correlate clinical response to this regimen in these patients with O6-alkylguanine DNA
alkyltransferase (AGT) depletion and baseline AGT in peripheral blood mononuclear cells and
tumor tissue.
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Thomas F. Gajewski, MD, PhD
Study Chair
University of Chicago
United States: Food and Drug Administration
NCI-2012-02340
NCT00005961
June 2000
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Evanston Northwestern Health Care | Evanston, Illinois 60201 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne, Indiana 46885-5099 |
Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
Central Illinois Hematology Oncology Center | Springfield, Illinois 62701 |
Michiana Hematology/Oncology P.C. | South Bend, Indiana 46617 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Mercy Ireland Cancer Center | Canton, Ohio 44708 |