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.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage IVA adult soft tissue sarcoma	Drug: carmustine  Drug: O6-benzylguanine	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

Illinois
      Cancer Care Specialists of Central Illinois, S.C., Decatur,  Illinois,  62526,  United States
      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States
      Division of Hematology/Oncology, Park Ridge,  Illinois,  60068,  United States
      Evanston Northwestern Health Care, Evanston,  Illinois,  60201,  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
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Indiana
      Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne,  Indiana,  46885-5099,  United States
      Michiana Hematology/Oncology P.C., South Bend,  Indiana,  46617,  United States

Study chairs or principal investigators

Christopher W. Ryan,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000067671; UCCRC-10227; UCCRC-T99-0088; NCI-T99-0088
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005066
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08