Cryosurgery in Treating Patients With Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00002863
• Other study ID #: CDR0000065134
• Secondary ID: LAC-USC-11S-96-1
• Status: Terminated
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: May 20, 2014
• Start date: June 1996
• Est. completion date: July 2000

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 2000
• Est. primary completion date: July 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• chemotherapy

Procedure:
• conventional surgery

• cryosurgery

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,