O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00004072

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

5.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: O6-benzylguanine Drug: carmustine	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1999

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
2	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065
3	MetroHealth Medical Center	Cleveland	Ohio	United States	44109