Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma
O6-benzylguanine
+ carmustine
Blood Protein Disorders+12
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: September 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.17 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed progressive multiple myeloma, meeting 1 of the following criteria: Previously untreated Primary refractory Relapsing disease Major criteria: Plasmacytomas on tissue biopsy Bone marrow plasmacytosis with greater than 30% plasma cells Monoclonal globulin spike on serum electrophoresis Greater than 3.5 g/dL for G peaks or greater than 2.0 g for A peaks Greater than 1.0 g/24 hours of kappa or lambda light chain excretion on urine electrophoresis in the absence of amyloidosis Minor criteria: 10%-30% bone marrow plasmacytosis (criterion A) Presence of monoclonal globulin spike but less than the levels under major criteria (criterion B) Lytic bone lesions (criterion C) IgM less than 50 mg/dL, IgA less than 100 mg/dL, or IgG less than 600 mg/dL (criterion D) Must meet one of the following: A minimum of 1 major criterion and 1 minor criterion 3 minor criteria, including criteria A and B PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,000/mm^3 Platelet count greater than 100,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin greater than 9 g/dL (transfusions allowed) Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 60 mL/min Calcium less than 14 mg/dL Pulmonary: No prior or concurrent active, symptomatic respiratory disease Corrected DLCO at least 60% predicted Other: Controlled diabetes mellitus allowed Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen containing an alkylating agent for multiple myeloma At least 4 weeks since prior chemotherapy Endocrine therapy: Prior corticosteroids for multiple myeloma allowed Radiotherapy: No prior pelvic radiotherapy or radiotherapy to more than 25% of bone marrow Surgery: Not specified
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
University of Chicago Cancer Research Center
Chicago, United StatesOpen University of Chicago Cancer Research Center in Google MapsIreland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, United StatesMetroHealth Medical Center
Cleveland, United States