Suspended

Cisplatin, Metronomic Low-Dose Interferon Alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer

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What is being tested

recombinant interferon alfa

+ cisplatin
+ gemcitabine hydrochloride
Biological
Drug
Procedure
Who is being recruted

Pancreatic Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2002

Summary

Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: February 13, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2002Actual date on which the first participant was enrolled.

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. 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 
Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: February 13, 2012
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 enrolledTotal 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.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pancreatic Cancer
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 HoustonHouston, United StatesSee the location

SuspendedOne Study Center