O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine; O(6)-benzylguanine

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