O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

Overview

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.

Full Title of Study: “Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2004

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.

Interventions

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Stanton L. Gerson, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • Overall Official(s)
    • Stanton L. Gerson, MD, Study Chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

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