RATIONALE: Cryosurgery kills cancer cells by freezing them. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cryosurgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of cryosurgery with or without chemotherapy in treating patients who have soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
recurrent childhood rhabdomyosarcoma recurrent childhood soft tissue sarcoma previously untreated childhood rhabdomyosarcoma recurrent adult soft tissue sarcoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma nonmetastatic childhood soft tissue sarcoma stage IVA adult soft tissue sarcoma stage III adult soft tissue sarcoma	Procedure: Cryosurgery for soft tissue sarcomas	Phase I

Further Study Details: 

OBJECTIVES: I. Assess the safety and morbidity associated with cryosurgical ablation in patients with soft tissue sarcomas of the extremity.

PROTOCOL OUTLINE: All patients undergo 1 session of cryoablation. Patients with high-grade sarcoma receive systemic chemotherapy 10-14 days after cryoablation at the discretion of the consulting medical oncologist, and undergo surgery 2-3 weeks following chemotherapy. Patients with low-grade sarcoma and those with high-grade sarcoma who do not receive chemotherapy undergo surgery 4-6 weeks after cryoablation. Surgery for all patients consists of en bloc resection or amputation, with limb salvage attempted when feasible.

Patients are followed weekly for 3 weeks.

PROJECTED ACCRUAL: A total of 12 patients (approximately 6 patients with low-grade, high-risk sarcoma and 6 with high-grade sarcoma) will be entered over approximately 6 months. The study will be suspended for the following: vascular complication that requires surgical intervention for correction in 2 patients; any neuropraxia that shows no evidence of resolution after 3 months in 2 patients; any wound complication that requires surgical correction in 4 patients; or any deep wound infection that requires surgical drainage in 4 patients.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Biopsy-proven soft tissue sarcoma (STS) of the extremity; Review by Pathology Department of the University of Southern California; CT or MRI required prior to biopsy
• Disease in one of the following categories: High-grade tumor; Low-grade tumor at high risk for local recurrence, i.e.: Adjacent to bone or vital neurovascular structures and able to be removed with a minimal surgical margin (i.e., plane of dissection goes through reactive zone of tumor)
• Lesion more than 5 cm in diameter
• The following tumors exclude: Primary sarcoma of the bone; Metastatic carcinoma; STS of the head and neck; Visceral STS, e.g., breast, uterus, spermatic cord, mediastinum chest wall; STS of the pelvis or retroperitoneum

--Prior/Concurrent Therapy--

• At least 30 days since therapy for sarcoma

--Patient Characteristics--

• Age: Any age
• Performance status: Not specified
• Hematopoietic: WBC at least 3,000; Platelets at least 75,000; Hemoglobin at least 9 g/Dl
• Hepatic: Bilirubin no greater than 1.5 mg/dL; AST/ALT no greater than 2.5 times normal
• Renal: Not specified
• Other: No concurrent disease that renders patient medically or psychologically unable to tolerate treatment

California
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States

Study chairs or principal investigators

Lawrence Menendez,  Study Chair,  University of Southern California   

Study ID Numbers:  CDR0000065134; LAC-USC-11S-96-1; NCI-V96-1059
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002863
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08