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Cryosurgery in Treating Patients With Soft Tissue Sarcoma

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chemotherapy
conventional surgery
cryosurgery
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring recurrent childhood rhabdomyosarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, previously untreated childhood rhabdomyosarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002863
Brief Title
Cryosurgery in Treating Patients With Soft Tissue Sarcoma
Official Title
PHASE I FEASIBILITY TRIAL OF CRYOSURGICAL ABLATION OF SOFT TISSUE SARCOMAS OF THE EXTREMETY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
June 1996 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
July 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
recurrent childhood rhabdomyosarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, previously untreated childhood rhabdomyosarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
cryosurgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Menendez, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0800
Country
United States

12. IPD Sharing Statement

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Cryosurgery in Treating Patients With Soft Tissue Sarcoma

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