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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004063 |
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 | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: recombinant interferon alfa Procedure: hyperthermia treatment |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 30 |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of cisplatin.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 joan.m.bull@uth.tmc.edu |
Study Chair: | Joan M.C. Bull, MD | The University of Texas Health Science Center, Houston |
Study ID Numbers: | CDR0000067264, UTHSC-MS-99116, NCI-V99-1561 |
Study First Received: | December 10, 1999 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00004063 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Interferon-alpha Fever Interferon Type I, Recombinant Cisplatin |
Interferons Interferon Alfa-2a Gemcitabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |