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O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
O6-benzylguanine
carmustine
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • MetroHealth Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
June 9, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004072
Brief Title
O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
Official Title
Phase II Trial of O6-Benzylguanine (NSC 637037) and BCNU in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
O6-benzylguanine
Intervention Description
Patients receive O6-benzylguanine 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.
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma.
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanton L. Gerson, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

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O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma

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