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


Phase 2
N/A
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.

Outcome Time Frame:

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.

Safety Issue:

No

Principal Investigator

Stanton L. Gerson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1A96

NCT ID:

NCT00004072

Start Date:

September 1999

Completion Date:

September 2004

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
MetroHealth Medical CenterCleveland, Ohio  44109