O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

NCT00004072 | Completed Phase 2 DMC

• 5 other identifiers: CWRU1A96U01CA062502P30CA043703CWRU-1A96NCI-T97-0021
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.

  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.

Interventions

O6-benzylguanine DRUG

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.

carmustine DRUG

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

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

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

O(6)-benzylguanine; Carmustine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Stanton L. Gerson, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: September 1, 1999
• Primary Completion: August 1, 2004
• Study Completion: September 1, 2004
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (3)