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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004063
Recruitment Status : Unknown
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 27, 2003
Last Update Posted : April 30, 2009
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: recombinant interferon alfa Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: hyperthermia treatment Phase 1 Phase 2

Detailed Description:


  • Determine the toxicity and tumor response in patients with metastatic, recurrent, or refractory malignancies treated with cisplatin, gemcitabine, interferon alfa, and long-duration, low temperature whole body hyperthermia (LL-WBH).

OUTLINE: This is a dose escalation study of cisplatin.

  • Phase I and II: Patients receive gemcitabine IV over 30 minutes on day 1 and 8. Patients receive cisplatin IV over 6 hours on day 15, followed by subcutaneous interferon alfa on days 16 and 17. Patients undergo long-duration, low temperature whole body hyperthermia over 6 hours plus gemcitabine over 30 minutes on day 17. Courses repeat every 5 weeks in the absence of disease progression or unacceptable toxicity.
  • Phase I: Cohorts of 3-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. The MTD of cisplatin is used for phase II study.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 1999
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Primary Outcome Measures :
  1. Response duration
  2. Duration of stable disease
  3. Overall survival
  4. Progression-free survival
  5. Time to response

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic, recurrent, or refractory carcinoma
  • Measurable disease by CT, MRI, or physical examination
  • No brain metastases or other CNS disorders



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks


  • 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


  • 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)


  • Creatinine no greater than 1.8 mg/dL
  • Creatinine clearance at least 45 mL/min
  • BUN no greater than 25 mg/dL


  • 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


  • 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


  • 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


Biologic therapy:

  • Not specified


  • Prior chemotherapy allowed

Endocrine therapy:

  • Not specified


  • Not specified


  • At least 6 days since major thoracic or abdominal surgery


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004063

United States, Texas
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77225
Contact: Joan M.C. Bull, MD    713-500-6820   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Study Chair: Joan M.C. Bull, MD The University of Texas Health Science Center, Houston

Responsible Party: Joan M.C. Bull, University of Texas Health Science Center at Houston Identifier: NCT00004063     History of Changes
Obsolete Identifiers: NCT00005929
Other Study ID Numbers: CDR0000067264
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 30, 2009
Last Verified: December 2008

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs