Suspended

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

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What is being tested

Data Collection

Who is being recruted

Hyperthermia+9

+ Body Temperature Changes

+ Digestive System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2002
See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine tumor response in patients with inoperable or metastatic pancreatic cancer treated with cisplatin, metronomic low-dose interferon alfa, gemcitabine, and fever-range whole-body hyperthermia. * Determine the toxicity of this regimen in these patients. * Determine the survival of patients treated with this regimen. * Determine changes in quality of life in patients treated with this regimen. Secondary * Determine whether inoperable tumors convert to operable in patients treated with this regimen. * Determine changes in cellular and cytokine immune function in patients treated with this regimen. OUTLINE: Patients are stratified according to disease stage (metastatic vs inoperable). Patients receive cisplatin IV over 4-6 hours on day 1, interferon alfa subcutaneously once daily on days 1-28, and gemcitabine IV over 1 hour on days 3 and 10. Patients undergo fever-range whole-body hyperthermia (40°C over 6 hours) on day 3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before each treatment course. PROJECTED ACCRUAL: A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 4 years.

Official TitleA 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 
NCT00082862
Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperthermiaBody Temperature ChangesDigestive System DiseasesDigestive System NeoplasmsEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasmsNeoplasms by SitePancreatic DiseasesPancreatic NeoplasmsWounds and InjuriesHeat Stress Disorders

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Texas Health Science Center at Houston

Houston, United StatesSee the location
SuspendedOne Study Center