Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma

Sarcoma Clinical Trial

Official title:

A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002974
• Other study ID #: CDR0000065489
• Secondary ID: WCCC-CO-9672NCI-
• Status: Completed
• Phase: Phase 2
• Start date: July 1996
• Est. completion date: April 2003

Study information

• Verified date: May 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with whole-body hyperthermia may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of whole-body hyperthermia plus combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or that cannot be surgically removed.

Description:

OBJECTIVES: I. Evaluate the combination of 41.8 degrees Celsius whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) chemotherapy in patients with advanced sarcoma. II. Assess the efficacy of this combination of therapy. III. Assess the clinical toxicity of WBH and ICE in these patients. IV. Obtain pilot data on the effect of WBH and ICE on cytokine induction in these patients.

OUTLINE: Treatment of whole body hyperthermia (WBH) and ifosfamide/carboplatin/etoposide (ICE) is given every 3-4 weeks. On day 1 of the treatment, ifosfamide is administered intravenously over 60 minutes at the beginning of hyperthermia. Carboplatin is administered intravenously over 20 minutes while at the maximum temperature. Etoposide is administered intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after hyperthermia. Patient disease status is reevaluated after 2 courses. If there is no disease progression, treatment continues for a maximum of 4 courses.

PROJECTED ACCRUAL: Approximately 17-34 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2003
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed advanced sarcoma that is metastatic or incurable surgically Evaluable or measurable disease Must be refractory to all known forms of effective therapy No CNS tumor involvement No major liver involvement (more than 33% replacement of liver by tumor)

PATIENT CHARACTERISTICS: Age: 18-65 Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC greater than 3,000/mm3 Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Alkaline phosphatase no greater than 3 times normal SGOT no greater than 3 times normal Protein no less than 15% below lower limit of normal Renal: BUN less than 30 mg/dL Creatinine less than 1.5 mg/dL OR Creatinine clearance no less than 60 mL/min Calcium no greater than 11.0 mg/dL Sodium 130-150 mmol/L Potassium 3.0-5.0 mmol/L Cardiovascular: No organic heart disease - coronary artery disease - history of angina - history of dysrhythmia requiring ongoing medical intervention - uncontrolled hypertension - patients that require beta blockers - congestive heart failure Neurologic: No tumor involvement of CNS No moderate or severe peripheral neuropathy No history of severe emotional instability by psychiatric history Pulmonary: FEV1 at least 60% of predicted Maximum voluntary volume at least 60% of predicted Partial pressure of oxygen at least 60 OR Oxygen saturation at least 90% Other: No history of secondary primary cancer which conceivably could be active No active nonmalignant gastric and/or duodenal ulcer No serious infection requiring hospitalization within the previous 14 days No history of hepatitis related to general anesthesia No history of allergy to lidocaine or related compound No development of malignant hyperthermia after general anesthesia No unexplained persistent fever Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 8 weeks since nitrosoureas (e.g., CCNU, BCNU, mitomycin) At least 4 weeks since any other chemotherapy Recovered from all toxic effects Endocrine therapy: Not specified Radiotherapy: No prior irradiation of more than 25% of the marrow Surgery: Not specified Other: No concurrent nonsteroidal anti-inflammatory agents or aspirin

Related Conditions & MeSH terms

• Fever
• Sarcoma

Intervention

Drug:
• carboplatin

• etoposide

• ifosfamide

Procedure:
• hyperthermia treatment

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,