Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027833
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-12-07
Brief Title:
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Phase II Study of Safety and Immunogenicity of an ALVAC-CEAB71 Vaccine Administered With Chemotherapy Alone or in Combination With Tetanus Toxoid as Compared to Chemotherapy Alone in Patients With Metastatic Colorectal Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2003-09
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 Vaccines may make the body build an immune response to kill tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Tetanus toxoid may make tumor cells more sensitive to chemotherapy and vaccine therapy
PURPOSE Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer
PURPOSE Randomized phase II trial to study the effectiveness of chemotherapy and vaccine therapy with or without tetanus toxoid compared with chemotherapy alone in treating patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Determine the safety of ALVAC-CEA-B71 vaccine and chemotherapy with or without tetanus toxoid vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma
Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive a priming dose of tetanus toxoid Beginning 2 weeks later patients receive tetanus toxoid and ALVAC-CEA-B71 vaccine subcutaneously SC once weekly for 3 weeks
Two weeks after the third vaccine administration patients receive tetanus toxoid and ALVAC-CEA-B71 vaccine SC on day 1 and irinotecan IV over 90 minutes leucovorin calcium IV and fluorouracil IV on days 1 8 15 and 22 Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive ALVAC-CEA-B71 vaccine and chemotherapy as in arm I
Arm III Patients receive chemotherapy as in arm I After completion of chemotherapy patients with partial or complete response may receive ALVAC-CEA-B71 vaccine SC once weekly on weeks 1-3 and 6
PROJECTED ACCRUAL A total of 90 patients 30 per treatment arm will be accrued for this study
Determine the safety of ALVAC-CEA-B71 vaccine and chemotherapy with or without tetanus toxoid vs chemotherapy alone in patients with metastatic colorectal adenocarcinoma
Determine whether tetanus toxoid enhances the immune response in patients treated with the vaccine and chemotherapy
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive a priming dose of tetanus toxoid Beginning 2 weeks later patients receive tetanus toxoid and ALVAC-CEA-B71 vaccine subcutaneously SC once weekly for 3 weeks
Two weeks after the third vaccine administration patients receive tetanus toxoid and ALVAC-CEA-B71 vaccine SC on day 1 and irinotecan IV over 90 minutes leucovorin calcium IV and fluorouracil IV on days 1 8 15 and 22 Treatment repeats every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive ALVAC-CEA-B71 vaccine and chemotherapy as in arm I
Arm III Patients receive chemotherapy as in arm I After completion of chemotherapy patients with partial or complete response may receive ALVAC-CEA-B71 vaccine SC once weekly on weeks 1-3 and 6
PROJECTED ACCRUAL A total of 90 patients 30 per treatment arm 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-G01-2033 | None | None | None |
| CPMC-14534 | None | None | None |
| CPMC-BB-IND-9911 | None | None | None |
| FCCC-01015 | None | None | None |
| APL-COL13 | None | None | None |