Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Combining hyperthermia with chemotherapy and interferon alfa may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of cisplatin, gemcitabine, interferon alfa, and whole-body hyperthermia and how well they work in treating patients with metastatic, recurrent, or refractory cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Cisplatin; Gemcitabine; Interferon-alpha; Interferons

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic, recurrent, or refractory carcinoma

• Measurable disease by CT, MRI, or physical examination

• No brain metastases or other CNS disorders

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 90,000/mm^3

• Bone marrow cellularity normal on bone marrow biopsy

• No coagulopathy disorder

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• SGOT no greater than 2 times upper limit of normal

• PT less than 14 seconds

• PTT less than 35 seconds

• No inadequate liver function (no greater than 20% involvement)

Renal:

• Creatinine no greater than 1.8 mg/dL

• Creatinine clearance at least 45 mL/min

• BUN no greater than 25 mg/dL

Cardiovascular:

• Adequate cardiac function documented by history, physical exam, or stress exercise test (MUGA or ECHO) with resting blood pressure and heart rate increasing appropriately with exercise

• LVEF at least 45%

• No prior myocardial infarction

• No symptomatic coronary artery disease

• No angina

• No significant arrhythmia

• No uncontrolled hypertension

• No thromboembolic disease

Pulmonary:

• FEV_1 at least 70% of predicted

• Arterial PO_2 at least 60 mmHg on room air

• No massive (greater than 30% involvement) lung disease

• DLCO greater than 50% of predicted

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• HIV negative

• No seizure disorders

• No significant emotional instability

• No history of malignant hyperthermia following general anesthesia

• No other concurrent medical illness that would prevent compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Prior chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• At least 6 days since major thoracic or abdominal surgery

Other:

• No concurrent cardiac glycosides, antiangina drugs, arrhythmia drugs, anticoagulants, thrombolytic agents, adrenal corticosteroids, or aspirin