RATIONALE: SU5416 may stop the growth of soft tissue sarcomas by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced, metastatic, or recurrent soft tissue sarcomas.

Condition	Treatment or Intervention	Phase
stage IVB adult soft tissue sarcoma gastrointestinal stromal tumor recurrent adult soft tissue sarcoma stage IVA adult soft tissue sarcoma stage III adult soft tissue sarcoma	Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Drug: SU5416	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response rate, response duration, and overall survival in patients with advanced, metastatic, or recurrent soft tissue sarcoma or gastrointestinal stromal tumor when treated with SU5416. II. Determine the safety of SU5416 in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced, metastatic, recurrent, or unresectable soft tissue sarcoma or gastrointestinal stromal tumor
• Measurable disease defined as lesions that can be measured in at least one dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
• Must have received prior chemotherapy with no response or progression after initial response
• Evidence of disease progression in past 3 months
• No CNS metastases or primary brain tumors

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent immunotherapy
• Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas); No concurrent chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 3 weeks since prior radiotherapy; No concurrent radiotherapy
• Surgery: Greater than 2 weeks since prior minor surgery (greater than 4 weeks since major surgery)
• Other: No concurrent antiinflammatory drugs

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: At least 12 weeks
• Hematopoietic: WBC greater than 2,000/mm3; Platelet count greater than 100,000/mm3; Fibrin split products no greater than 0.001 mg; Fibrinogen greater than 200 mg/dL
• Hepatic: Bilirubin no greater than upper limit of normal (ULN); AST/ALT less than 1.5 times ULN; PT/PTT less than 1.25 times ULN
• Renal: Creatinine no greater than 1.5 mg/dL
• Cardiovascular: At least 1 year since bypass surgery for atherosclerotic coronary artery disease; No uncompensated coronary artery disease; No history of myocardial infarction or unstable/severe angina in past 6 months; No severe peripheral vascular disease; No history of deep venous or arterial thrombosis in past 3 months
• Pulmonary: No history of pulmonary embolism in past 3 months
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No diabetes mellitus; No history of bleeding diathesis; No known active retroviral disease; No AIDS-associated Kaposi's sarcoma; No history of allergic reaction to Cremophor or paclitaxel; No uncontrolled illness or psychiatric disorder that would preclude study

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Study chairs or principal investigators

George Daniel Demetri,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000067893; DFCI-00002; NCI-330
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005862
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08