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O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma Clinical research trials and O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma. O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma clinical trial. Human subjects often get the best healthcare available for their O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma  O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
For Condition: stage 4B adult soft tissue sarcoma,recurrent adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
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 and carmustine in treating patients who have recurrent , metastatic, or locally advanced soft tissue sarcoma.
Details: OBJECTIVES: I. Determine the objective response rate of patients with recurrent, metastatic, or locally advanced soft tissue sarcoma treated with O6-benzylguanine and carmustine. II. Determine the toxicity of this regimen in this patient population. III. Determine the duration of response, time to progression, and survival of these patients treated with this regimen. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed recurrent, metastatic, or locally advanced soft tissue sarcoma considered incurable by surgery or radiotherapy - Bidimensionally measurable disease; At least 1 cm x 1 cm, with clearly defined margins on CT scan, X-ray, or physical examination; Located outside of radiation port or evidence of progression within radiation port - No CNS disease only - No uncontrolled symptomatic brain metastases regardless of other disease sites --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherRyan, Study Chair, University of Chicago Cancer Research Center
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Additional Information:
Study ID Numbers: CDR0000067671; UCCRC-10227,UCCRC-T99-0088,NCI-T99-0088
Study Start Date: June 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005066
Other Stage 4a Adult Soft Tissue Sarcoma Studies:
1. O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
2. Interferon alfa and Thalidomide in Treating Patients With Soft Tissue Sarcoma or Bone Sarcoma
3. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer
4. Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
5. Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
Related Studies:
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O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue Sarcoma
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