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O6-Benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
This study has been completed.
Study NCT00004072   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: November 16, 2008   History of Changes

December 10, 1999
November 16, 2008
September 1999
 
 
 
Complete list of historical versions of study NCT00004072 on ClinicalTrials.gov Archive Site
 
 
 
O6-Benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma

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.

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.

Phase II
Interventional
Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: O6-benzylguanine
  • Drug: carmustine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004072
 
CDR0000067280, CWRU-1A96, NCI-T97-0021
Ireland Cancer Center
National Cancer Institute (NCI)
Study Chair: Stanton L. Gerson, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP