O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00004072|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: O6-benzylguanine Drug: carmustine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma|
|Study Start Date :||September 1999|
|Actual Primary Completion Date :||August 2004|
|Actual Study Completion Date :||September 2004|
U.S. FDA Resources
- Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma. [ Time Frame: 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004072
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Study Chair:||Stanton L. Gerson, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|