Clinical trial · Interventional
Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer
A Phase I-II Clinical Trial of Cisplatin (Platinol) Followed by Gemcitabine HCl (Gemzar) in Combination With Mild, Fever-Range Whole Body Hyperthermia (LL-WBH) at 40C in Patients With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| hyperthermia treatment | Procedure | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Response duration
- measure
- Duration of stable disease
- measure
- Overall survival
- measure
- Progression-free survival
- measure
- Time to response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available