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


Phase 1
N/A
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lawrence Menendez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065134

NCT ID:

NCT00002863

Start Date:

June 1996

Completion Date:

July 2000

Related Keywords:

  • Sarcoma
  • 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
  • Sarcoma

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800