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

Phase 1

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00004063
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 1999-08
• Study First Submitted: 1999-12-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2008-12
• Last Update Submitted: 2009-04-29
• Last Update Posted: 2009-04-30
• Primary Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response duration
Duration of stable disease
Overall survival
Progression-free survival
Time to response

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States