Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082862
Status:
UNKNOWN
Last Update Posted:
2012-02-13
First Post:
2004-05-14
Brief Title:
Cisplatin Metronomic Low-Dose Interferon Alfa Gemcitabine and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
Sponsor:
The University of Texas Health Science Center Houston
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Clinical Trial of a TimingSchedule Optimized Combined-Modality Regimen Cisplatin Metronomic Low-Dose Interferon-α IFN-α Followed by Gemcitabine HCl GEMZAR in Combination With Mild Fever-Range Whole-Body Hyperthermia FR-WBH in Patients With Advanced Inoperable Pancreatic Cancer
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 such as cisplatin and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving low-dose interferon alfa on a metronomic regularly timed schedule may stop the growth of cancer by stopping blood flow to the tumor Fever-range above 101 F whole-body hyperthermia kills tumor cells by heating them to several degrees above normal body temperature Combining cisplatin gemcitabine and low-dose interferon alfa with fever-range whole-body hyperthermia may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cisplatin gemcitabine and metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works in treating patients with inoperable or metastatic pancreatic cancer
PURPOSE This phase II trial is studying how well giving cisplatin gemcitabine and metronomic low-dose interferon alfa together with fever-range whole-body hyperthermia works in treating patients with inoperable or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine tumor response in patients with inoperable or metastatic pancreatic cancer treated with cisplatin metronomic low-dose interferon alfa gemcitabine and fever-range whole-body hyperthermia
Determine the toxicity of this regimen in these patients
Determine the survival of patients treated with this regimen
Determine changes in quality of life in patients treated with this regimen
Secondary
Determine whether inoperable tumors convert to operable in patients treated with this regimen
Determine changes in cellular and cytokine immune function in patients treated with this regimen
OUTLINE Patients are stratified according to disease stage metastatic vs inoperable
Patients receive cisplatin IV over 4-6 hours on day 1 interferon alfa subcutaneously once daily on days 1-28 and gemcitabine IV over 1 hour on days 3 and 10 Patients undergo fever-range whole-body hyperthermia 40C over 6 hours on day 3 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then before each treatment course
PROJECTED ACCRUAL A total of 18-48 patients 9-24 per stratum will be accrued for this study within 4 years
Primary
Determine tumor response in patients with inoperable or metastatic pancreatic cancer treated with cisplatin metronomic low-dose interferon alfa gemcitabine and fever-range whole-body hyperthermia
Determine the toxicity of this regimen in these patients
Determine the survival of patients treated with this regimen
Determine changes in quality of life in patients treated with this regimen
Secondary
Determine whether inoperable tumors convert to operable in patients treated with this regimen
Determine changes in cellular and cytokine immune function in patients treated with this regimen
OUTLINE Patients are stratified according to disease stage metastatic vs inoperable
Patients receive cisplatin IV over 4-6 hours on day 1 interferon alfa subcutaneously once daily on days 1-28 and gemcitabine IV over 1 hour on days 3 and 10 Patients undergo fever-range whole-body hyperthermia 40C over 6 hours on day 3 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and then before each treatment course
PROJECTED ACCRUAL A total of 18-48 patients 9-24 per stratum will be accrued for this study within 4 years
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 |
|---|---|---|---|
| UTHSC-MS-02117 | None | None | None |