Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004063
Status:
UNKNOWN
Last Update Posted:
2009-04-30
First Post:
1999-12-10
Brief Title:
Cisplatin Gemcitabine Interferon Alfa and Hyperthermia in Treating Patients With Advanced Cancer
Sponsor:
The University of Texas Health Science Center Houston
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 III 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
PURPOSE This phase III 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V99-1561 | None | None | None |
| UTHSC-MS-99116 | None | None | None |