Clinical Trial: O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

This study has been completed.

Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
refractory plasma cell neoplasm
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: O6-benzylguanine
 Drug: carmustine
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphatic Diseases;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of O6-Benzylguanine Combined With Carmustine in Patients With Previously Untreated or Refractory Multiple Myeloma

Further Study Details: 

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.

Eligibility

Genders Eligible for Study:  Both

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:

Endocrine therapy:

Radiotherapy:

Surgery:

  • Not specified

Location Information


Illinois
      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States

      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201-1781,  United States

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States

      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States

      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61602,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

      University of Illinois Medical Center, Chicago,  Illinois,  60612,  United States

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States

      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States

Michigan
      Oncology Care Associates, P.L.L.C., Saint Joseph,  Michigan,  49085,  United States

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Stanton L. Gerson, MD,  Study Chair,  Ireland Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067280; CWRU-1A96; NCI-T97-0021
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004072
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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