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Home > "O" Clinical Trials Conditions > O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma  O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
For Condition: stage 3 multiple myeloma,stage 2 multiple myeloma,refractory plasma cell neoplasm,stage 1 multiple myeloma
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 relapsingmultiple myeloma.
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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StantonGerson, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Stanton Gerson 216-368-1177
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Lutheran General Cancer Care Center *Recruiting*
Park Ridge, Illinois, 60068
United States
Recruiting Brian Samuels 847-268-8200
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 219-484-8830
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Gregory Masters 847-570-2515
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Stuart Krauss 773-878-8700
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Todd Zimmerman 773-702-9200
Oncology Care Associates, P.L.L.C. *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
University of Illinois Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-7297
Additional Information:
Study ID Numbers: CDR0000067280; CWRU-1A96,NCI-T97-0021
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004072
Other Refractory Plasma Cell Neoplasm Studies:
1. Tandem Autologous Stem Cell Transplantation With or Without Maintenance Therapy After the Second Transplantation Compared With Autologous Stem Cell Transplantation Followed By Matched Sibling Allogeneic Stem Cell Transplantation in Patients With Stage II or Stage III Multiple Myeloma
2. Melphalan, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Multiple Myeloma
3. Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Previously Untreated Multiple Myeloma
5. Combination Chemotherapy, Peripheral Stem Cell Transplantation, Biological Therapy, Pamidronate and Thalidomide in Treating Patients With Multiple Myeloma
Related Studies:
Other refractory plasma cell neoplasm Clinical Trials
Other Indiana Clinical Trials
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O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
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