O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004072
• Other study ID #: CWRU1A96
• Secondary ID: U01CA062502P30CA
• Status: Completed
• Phase: Phase 2
• First received: December 10, 1999
• Last updated: June 9, 2010
• Start date: September 1999
• Est. completion date: September 2004

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No