Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00009958
Status:
TERMINATED
Last Update Posted:
2013-05-16
First Post:
2001-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy With or Without Sargramostim in Treating Patients With Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I Study of Sequential Vaccinations With Fowlpox-CEA(6D)-TRICOM (B7.1/ICAM/LFA-3) Alone, and in Combination With Vaccinia-CEA(6D)-TRICOM, and the Role of GM-CSF, in Patients With CEA Expressing Carcinomas
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
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:
Phase I trial to compare the effectiveness of vaccine therapy with or without sargramostim in treating patients who have solid tumors. Vaccines may make the body build an immune response to kill tumor cells. Combining colony-stimulating factors such as sargramostim with vaccines may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose and toxicity profile of the novel CEA-based vaccine, rF-CEA(6D)-TRICOM (recombinant fowlpox-CEA(6D)-B7.1/ICAM-1/LFA-3), either alone or in combination with a second vaccine, rV-CEA(6D)-TRICOM (recombinant vaccinia-CEA(6D)-B7.1/ICAM-1/LFA-3) in patients with advanced CEA-bearing cancers.
II. To determine the maximum tolerated dose and toxicity profile of the novel CEA-based vaccine rV-CEA(6D)-TRICOM when given in combination with the maximum tolerated dose of rF-CEA(6D)-TRICOM, in patients with advanced CEA-bearing cancers.
III. To determine the safety and impact of colony stimulating factors (GM-CSF) on the immunologic response, when given in conjunction with the combination of rV-CEA(6D)-TRICOM (MTD) and rF-CEA(6D)-TRICOM (MTD) vaccines, in patients with advanced CEA-bearing cancers.
IV. To determine the change in CAP-1 directed T cells in patients treated with these vaccines using ELISPOT assay analysis.
V. To perform a pilot analysis of the impact of vaccine therapy on the quantity of circulating CEA-positive cells in the patients treated on this study in order to develop and eventually validate a practical, intermediate bio-marker for the immunologic response to the vaccines.
VI. To document any objective anti-tumor responses that occur.
OUTLINE: This is a dose-escalation study of fowlpox-CEA-TRICOM (fCEA-TRI) vaccine and vaccinia-CEA-TRICOM (vCEA-TRI) vaccine.
STAGE I: Patients receive fCEA-TRI vaccine subcutaneously (SC) once daily on days 1, 29, 57, and 85.
Cohorts of 3-10 patients receive escalating doses of the fCEA-TRI vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT).
STAGE II: Patients receive vCEA-TRI vaccine intradermally once on day 1 and fCEA-TRI vaccine SC at the MTD determined in stage I once daily on days 29, 57, and 85.
Cohorts of 3-10 patients receive escalating doses of the vCEA-TRI vaccine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.
STAGE III: A single cohort of 6-10 patients receive both vaccines as in stage II, at the MTDs determined in stages I and II, and sargramostim (GM-CSF) SC once daily on days 1-4, 29-32, 57-60, and 85-88.
Patients in any stage of the study with responding disease may receive additional doses of the fCEA-TRI vaccine monthly for 2 months and then every 3 months thereafter. Patients who have objective evidence of response (including mixed response) and/or a fall in an elevated serum CEA level after the sixth vaccine and who subsequently develop disease progression while on the extended every 3-month treatment schedule and have no other potentially better treatment alternatives available may continue treatment as per the monthly vaccination schedule for 2 additional months. Patients with stable or responding disease after those two monthly vaccines may continue monthly vaccines at the discretion of the principal investigator.
Patients are followed at 4 weeks and then monthly for 3 months.
I. To determine the maximum tolerated dose and toxicity profile of the novel CEA-based vaccine, rF-CEA(6D)-TRICOM (recombinant fowlpox-CEA(6D)-B7.1/ICAM-1/LFA-3), either alone or in combination with a second vaccine, rV-CEA(6D)-TRICOM (recombinant vaccinia-CEA(6D)-B7.1/ICAM-1/LFA-3) in patients with advanced CEA-bearing cancers.
II. To determine the maximum tolerated dose and toxicity profile of the novel CEA-based vaccine rV-CEA(6D)-TRICOM when given in combination with the maximum tolerated dose of rF-CEA(6D)-TRICOM, in patients with advanced CEA-bearing cancers.
III. To determine the safety and impact of colony stimulating factors (GM-CSF) on the immunologic response, when given in conjunction with the combination of rV-CEA(6D)-TRICOM (MTD) and rF-CEA(6D)-TRICOM (MTD) vaccines, in patients with advanced CEA-bearing cancers.
IV. To determine the change in CAP-1 directed T cells in patients treated with these vaccines using ELISPOT assay analysis.
V. To perform a pilot analysis of the impact of vaccine therapy on the quantity of circulating CEA-positive cells in the patients treated on this study in order to develop and eventually validate a practical, intermediate bio-marker for the immunologic response to the vaccines.
VI. To document any objective anti-tumor responses that occur.
OUTLINE: This is a dose-escalation study of fowlpox-CEA-TRICOM (fCEA-TRI) vaccine and vaccinia-CEA-TRICOM (vCEA-TRI) vaccine.
STAGE I: Patients receive fCEA-TRI vaccine subcutaneously (SC) once daily on days 1, 29, 57, and 85.
Cohorts of 3-10 patients receive escalating doses of the fCEA-TRI vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT).
STAGE II: Patients receive vCEA-TRI vaccine intradermally once on day 1 and fCEA-TRI vaccine SC at the MTD determined in stage I once daily on days 29, 57, and 85.
Cohorts of 3-10 patients receive escalating doses of the vCEA-TRI vaccine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.
STAGE III: A single cohort of 6-10 patients receive both vaccines as in stage II, at the MTDs determined in stages I and II, and sargramostim (GM-CSF) SC once daily on days 1-4, 29-32, 57-60, and 85-88.
Patients in any stage of the study with responding disease may receive additional doses of the fCEA-TRI vaccine monthly for 2 months and then every 3 months thereafter. Patients who have objective evidence of response (including mixed response) and/or a fall in an elevated serum CEA level after the sixth vaccine and who subsequently develop disease progression while on the extended every 3-month treatment schedule and have no other potentially better treatment alternatives available may continue treatment as per the monthly vaccination schedule for 2 additional months. Patients with stable or responding disease after those two monthly vaccines may continue monthly vaccines at the discretion of the principal investigator.
Patients are followed at 4 weeks and then monthly for 3 months.
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?: