O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
NCT ID: NCT00005066
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2000-06-30
2002-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining O6-benzylguanine and carmustine in treating patients who have recurrent, metastatic, or locally advanced soft tissue sarcoma.
Detailed Description
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OUTLINE: Patients receive O6-benzylguanine IV over 1 hour followed 1 hour later by carmustine IV over 15 minutes. Treatment continues every 6 weeks for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients with progressive disease are followed every 6 months until death. Patients without progressive disease are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 14 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
O6-BG as an intravenous infusion (through your vein) over 1 hour followed 1 hour later by BCNU intravenously over 15 minutes. chemotherapy every 6 weeks.
O6-benzylguanine
carmustine
Interventions
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O6-benzylguanine
carmustine
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal unless due to Gilbert's syndrome SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Pulmonary: DLCO at least 80% predicted Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent significant underlying medical or psychiatric illness (e.g., active infection) that would preclude study treatment or exceptionally increase risk of toxicities No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease At least 4 weeks since prior neoadjuvant and/or adjuvant chemotherapy No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy to any lesion Surgery: See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Walter M. Stadler, MD, FACP
Role: STUDY_CHAIR
University of Chicago
Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Division of Hematology/Oncology
Park Ridge, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, United States
Countries
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Other Identifiers
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UCCRC-10227
Identifier Type: -
Identifier Source: secondary_id
UCCRC-T99-0088
Identifier Type: -
Identifier Source: secondary_id
NCI-T99-0088
Identifier Type: -
Identifier Source: secondary_id
10227
Identifier Type: -
Identifier Source: org_study_id