Cryosurgery in Treating Patients With Soft Tissue Sarcoma

Sponsor

University of Southern California (Other)

Overall Status

Terminated

CT.gov ID

NCT00002863

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: chemotherapy Procedure: conventional surgery Procedure: cryosurgery	Phase 1

Detailed Description

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PHASE I FEASIBILITY TRIAL OF CRYOSURGICAL ABLATION OF SOFT TISSUE SARCOMAS OF THE EXTREMETY

Study Start Date :

Jun 1, 1996

Actual Primary Completion Date :

Jul 1, 2000

Actual Study Completion Date :

Jul 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

PRIOR CONCURRENT THERAPY: At least 30 days since therapy for sarcoma