Radiation Therapy With or Without SU5416 in Treating Patients With Soft Tissue Sarcoma

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if radiation therapy is more effective with or without SU5416 in treating soft tissue sarcoma.

PURPOSE: Phase I/II trial to compare the effectiveness of radiation therapy with or without SU5416 in treating patients who have stage IB or stage IIA soft tissue sarcoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Semaxinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary or locally recurrent stage IB or IIA soft tissue sarcoma

• Grade 1 or 2

• Tumor greater than 5 cm in diameter

• Tumor located on upper extremities (including shoulder), lower extremities (including hip), or body wall

• No sarcoma of the head and neck or intra-abdominal or retroperitoneal sarcoma

• No desmoid tumor or dermatofibrosarcoma protuberans

• No metastatic disease

• No evidence of lung metastases

• Maximum of 4 lung lesions no greater than 5 mm in diameter each on preoperative chest CT scan allowed OR

• Lesion no greater than 1 cm allowed if stable for at least 1 year and fits criteria for granuloma

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-1

Life expectancy:

• At least 2 years

Hematopoietic:

• WBC at least 4,000/mm^3 OR

• Absolute neutrophil count at least 1,800/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 50 U/L

• PT and PTT less than 1.25 times normal (not on warfarin)

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• No congestive heart failure or myocardial infarction within the past 6 months

• No uncompensated coronary artery disease

• No severe peripheral vascular disease

• No peripheral vascular disease with diabetes mellitus

• No deep venous or arterial thrombosis within the past 3 months

• Fibrin split products less than 2 times normal

• Fibrinogen greater than 200 mg/dL

Pulmonary:

• No pulmonary embolism within the past 3 months

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No contraindications to surgery

• No active uncontrolled bacterial, viral, or fungal infection

• No other prior or concurrent malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

• No other serious medical or psychiatric illness that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy for soft tissue sarcoma

Chemotherapy:

• No prior chemotherapy for soft tissue sarcoma

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for soft tissue sarcoma

Surgery:

• At least 2 weeks since prior minor surgery (e.g., port placement)

• At least 4 weeks since prior major surgery