Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003780
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Chemotherapy Compared to Biological Therapy in Treating Patients With Cancer of the Pancreas
Sponsor:
Meyer Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Randomized Trial Comparing the Safety and Efficacy of Systemic Chemotherapy Gemcitabine to Immunotherapy CYTOIMPLANT - Intra Tumor Implants of Allogeneic Peripheral Blood Mononuclear Cells Sensitized Against Patient Alloantigens by Mixed Lymphocyte Culture as First Line Therapy for Patients With Unresectable Locally Advanced and Metastatic Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing It is not yet known whether chemotherapy is more effective than biological therapy in treating patients with cancer of the pancreas
PURPOSE Randomized phase II trial to compare the effectiveness of gemcitabine with biological therapy in treating patients who have cancer of the pancreas that cannot be surgically removed
PURPOSE Randomized phase II trial to compare the effectiveness of gemcitabine with biological therapy in treating patients who have cancer of the pancreas that cannot be surgically removed
Detailed Description:
OBJECTIVES I Compare the efficacy of CYTOIMPLANT intratumor implants of allogeneic peripheral blood mononuclear cells sensitized against patient alloantigens by mixed lymphocyte culture vs gemcitabine in patients with unresectable locally advanced or metastatic pancreatic cancer II Compare the overall survival progression free survival objective tumor response time to treatment failure and quality of life of these patients III Compare the safety and toxicities of CYTOIMPLANT vs gemcitabine in these patients
OUTLINE This is a randomized open label multicenter study Patients are randomly assigned 21 ratio in favor of CYTOIMPLANT arm to one of two treatment arms Arm I Patients receive gemcitabine IV weekly for 7 weeks followed by 1 week of rest In subsequent courses patients then receive gemcitabine IV weekly for 3 weeks followed by a week of rest Courses are repeated every 4 weeks in the absence of disease progression or unacceptable toxicity Arm II Patients undergo leukapheresis to collect lymphocytes Patient lymphocytes are mixed with donor lymphocytes at the sponsor labs The mixture is implanted into the tumor using endoscopic ultrasound guided fine needle injection This process may be repeated in the fifth month using different donors lymphocytes Follow up assessments may include physical exams lab tests CT scans and quality of life assessments at 4 weeks and at 3 5 7 9 and 12 months from the date of randomization Patients are then contacted every 3 months to assess status
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patients are randomly assigned 21 ratio in favor of CYTOIMPLANT arm to one of two treatment arms Arm I Patients receive gemcitabine IV weekly for 7 weeks followed by 1 week of rest In subsequent courses patients then receive gemcitabine IV weekly for 3 weeks followed by a week of rest Courses are repeated every 4 weeks in the absence of disease progression or unacceptable toxicity Arm II Patients undergo leukapheresis to collect lymphocytes Patient lymphocytes are mixed with donor lymphocytes at the sponsor labs The mixture is implanted into the tumor using endoscopic ultrasound guided fine needle injection This process may be repeated in the fifth month using different donors lymphocytes Follow up assessments may include physical exams lab tests CT scans and quality of life assessments at 4 weeks and at 3 5 7 9 and 12 months from the date of randomization Patients are then contacted every 3 months to assess status
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MEYER-AIT-PAN-201 | None | None | None |