O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

NCT ID: NCT00004072

Last Updated: 2010-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2004-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Stanton L. Gerson, MD

Role: STUDY_CHAIR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

U01CA062502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-1A96

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-T97-0021

Identifier Type: -

Identifier Source: secondary_id

CWRU1A96

Identifier Type: -

Identifier Source: org_study_id