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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)
ClinicalTrials.gov Identifier: NCT00004072
  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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: O6-benzylguanine
Drug: carmustine
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Carmustine O(6)-Benzylguanine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1999
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004072

Locations
United States, Illinois
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States, 49085
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Stanton L. Gerson, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000067280, CWRU-1A96, NCI-T97-0021
Study First Received: December 10, 1999
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00004072  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Carmustine
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
O(6)-benzylguanine
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009