Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma
OBJECTIVES:
- Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with
previously untreated or refractory multiple myeloma.
- Assess the effects of O6-benzylguanine on bone marrow myeloma cells in this patient
population.
OUTLINE: Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by
carmustine IV over 60 minutes. Courses repeat every 6 weeks in the absence of disease
progression or unacceptable toxicity. Patients receive 2 additional courses beyond
attainment of best response (partial or complete response or stable or plateau disease).
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
Every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond attainment of best response. Patients are followed every 2 months.
No
Stanton L. Gerson, MD
Study Chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
CWRU1A96
NCT00004072
September 1999
September 2004
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |