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.

Condition	Treatment or Intervention	Phase
recurrent adult soft tissue sarcoma	Drug: carboplatin  Drug: etoposide  Drug: ifosfamide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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)

--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

--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

Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States

Study chairs or principal investigators

H. Ian Robins,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000065489; WCCC-CO-9672; NCI-G97-1217
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002974
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08