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

Phase 2
18 Years
65 Years
Not Enrolling

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Trial Information

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

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.

Inclusion 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)

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

H. I. Robins, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Federal Government

Study ID:




Start Date:

July 1996

Completion Date:

April 2003

Related Keywords:

  • Sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Fever
  • Sarcoma



University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792