NCT00004072

O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine with carmustine in treating patients who have previously untreated, refractory, or relapsing multiple myeloma.

Detailed description

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	O6-benzylguanine	Patients receive O6-benzylguanine 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.
DRUG	carmustine	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.

Timeline

• Start date: 1999-09-01
• Primary completion: 2004-08-01
• Completion: 2004-09-01
• First posted: 2003-01-27
• Last updated: 2010-06-11

Locations

3 sites across 1 country: United States