Clinical trial · Interventional
Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
A Phase II Clinical Trial of a Timing/Schedule Optimized Combined-Modality Regimen: Cisplatin + Metronomic Low-Dose Interferon-α (IFN-α) Followed by Gemcitabine HCl (GEMZAR) in Combination With Mild, Fever-Range Whole-Body Hyperthermia (FR-WBH) in Patients With Advanced, Inoperable Pancreatic Cancer
- 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, such as cisplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving low-dose interferon alfa on a metronomic (regularly timed) schedule may stop the growth of cancer by stopping blood flow to the tumor. Fever-range (above 101° F) whole-body hyperthermia kills tumor cells by heating them to several degrees above normal body temperature. Combining cisplatin, gemcitabine, and low-dose interferon alfa with fever-range whole-body hyperthermia may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin, gemcitabine, and metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works in treating patients with inoperable or metastatic pancreatic 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
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 (4)
- measure
- Tumor response
- measure
- Toxicity
- measure
- Survival
- measure
- Changes in quality of life
Secondary outcomes (2)
- measure
- Conversion of inoperable tumors to operable
- measure
- Changes in cellular and cytokine immune function
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic carcinoma * Inoperable or metastatic disease * Measurable lesion by physical examination, CT scan, or MRI * Carcinomatous hepatomegaly is considered measurable if a palpable liver edge clearly extends \> 15 cm below the costal margin or xiphoid process * No known brain metastases by CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin \> 10.0 g/dL * Platelet count ≥ 90,000/mm\^3 * Bone marrow cellularity normal on bone marrow biopsy * No serious coagulopathy disorder Hepatic * Bilirubin ≤ 2.5 mg/dL * SGPT and SGOT ≤ 2 times upper limit of normal * PT \< 14 seconds * PTT \< 35 seconds * INR \< 1.5 Renal * Creatinine ≤ 1.8 mg/dL * Creatinine clearance ≥ 45 mL/min * Blood urea nitrogen ≤ 25 mg/dL Cardiovascular * Adequate cardiovascular function as documented by the following: * History and physical examination * Stress exercise test (MUGA or echocardiogram) with resting blood pressure, heart rate, and LVEF that increase appropriately with exercise * LVEF ≥ 45% * No myocardial infarction within the past 6 months * No symptomatic coronary artery disease * No angina * No unstable blood pressure * No congestive heart failure * No significant arrhythmia * No conduction disturbance * No thromboembolic disease * No uncontrolled hypertension Pulmonary * Complete pulmonary function studies with the following arterial blood gas values: * FEV\_1 ≥ 70% of predicted * Arterial PO\_2 ≥ 60 mm Hg on room air * PCO\_2 appropriate * pH appropriate * No massive (≥ 30%) lung disease * DLCO \> 50% of predicted Other * No prior or concurrent seizures or other CNS disorders * No prior malignant hyperthermia after general anesthesia * No insulin-dependent diabetes mellitus * No significant emotional instability * No other medical problem that would preclude treatment with whole-body hyperthermia * HIV negative * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed Chemotherapy * No prior cisplatin or gemcitabine Endocrine therapy * No concurrent adrenal corticosteroids Radiotherapy * More than 3 weeks since prior radiotherapy Surgery * More than 6 days since prior major thoracic or abdominal surgery * Prior surgical resection of tumor with subsequent recurrence allowed Other * No concurrent cardiac glycosides * No concurrent anti-angina or arrhythmia drugs * No concurrent thrombolytic agents * No concurrent anticoagulants * No concurrent aspirin
References
Publications (1)
- RESULTBull JM, Scott GL, Strebel FR, Nagle VL, Oliver D, Redwine M, Rowe RW, Ahn CW, Koch SM. Fever-range whole-body thermal therapy combined with cisplatin, gemcitabine, and daily interferon-alpha: a description of a phase I-II protocol. Int J Hyperthermia. 2008 Dec;24(8):649-62. doi: 10.1080/02656730802104740. PMID 18608594