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
- 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
- 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.
Primary Purpose: Treatment
Joan M.C. Bull, MD
The University of Texas Health Science Center, Houston
|University of Texas Health Science Center at Houston||Houston, Texas 77225|