Cisplatin, Gemcitabine, Interferon Alfa, and Hyperthermia in Treating Patients With Advanced Cancer
Recruitment status was: Recruiting
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.
Unspecified Adult Solid Tumor, Protocol Specific
Biological: recombinant interferon alfa
Drug: gemcitabine hydrochloride
Procedure: hyperthermia treatment
|Study Design:||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|
- Response duration [ Designated as safety issue: No ]
- Duration of stable disease [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Time to response [ Designated as safety issue: No ]
|Study Start Date:||August 1999|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004063
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77225|
|Study Chair:||Joan M.C. Bull, MD||The University of Texas Health Science Center, Houston|