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| Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002974 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: carboplatin Drug: etoposide Drug: ifosfamide Procedure: hyperthermia treatment |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients |
| Estimated Enrollment: | 34 |
| Study Start Date: | July 1996 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Study Chair: | H. I. Robins, MD, PhD | University of Wisconsin, Madison |
More Information
| Study ID Numbers: | CDR0000065489, WCCC-CO-9672, NCI-G97-1217 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002974 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
|
Carboplatin Etoposide phosphate Recurrence Fever Neoplasms, Connective and Soft Tissue Malignant Mesenchymal Tumor Soft Tissue Sarcomas |
Ifosfamide Sarcoma Antineoplastic Agents, Alkylating Etoposide Alkylating Agents Isophosphamide mustard |
|
Neoplasms, Connective and Soft Tissue Ifosfamide Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Carboplatin Alkylating Agents Pharmacologic Actions |