Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217373
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2005-09-20
Brief Title:
Vaccine Therapy GM-CSF and Interferon Alfa-2b in Treating Patients With Locally Advanced or Metastatic Cancer That Expresses Carcinoembryonic Antigen CEA
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Sequential Vaccinations With Fowlpox-CEA6D-Tricom B71ICAMLFA3 and Vaccinia-CEA 6D-Tricom in Combination With GM-CSF and Interferon-Alfa-2B in Patients With CEA-Expressing Carcinomas
Status:
COMPLETED
Status Verified Date:
2014-12
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:
This phase I trial is studying the side effects and best dose of interferon alfa-2b when given together with vaccine therapy and GM-CSF in treating patients with locally advanced or metastatic cancer that makes CEA Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells that make carcinoembryonic antigen CEA Biological therapies such as GM-CSF may stimulate the immune system in different ways and stop cancer cells from growing Interferon alfa-2b may interfere with the growth of cancer cells and slow cancer growth Giving vaccine therapy together with GM-CSF and interferon alfa-2b may kill more cancer cells that make CEA
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended phase II dose of interferon alfa-2b IFN-α-2b when administered with recombinant vaccinia-CEA6D-TRICOM vaccine recombinant fowlpox-CEA6D-TRICOM vaccine and sargramostim GM-CSF in patients with locally advanced or metastatic carcinoembryonic antigen CEA-expressing carcinoma
SECONDARY OBJECTIVES
I Determine the effect of IFN-α-2b on tumor cell expression of CEA and MHC class I antigens in patients treated with this regimen
II Determine the immunologic effects of this regimen in these patients III Determine any objective anti-tumor responses that may occur in response to this regimen in these patients
IV Determine the time to tumor progression in patients treated with this regimen
OUTLINE This is a dose-escalation study of interferon alfa-2b IFN-α-2b
COURSE I Patients receive recombinant vaccinia-CEA6D-TRICOM vaccine subcutaneously SC on day 1 Patients also receive sargramostim GM-CSF SC on days 1-4 and IFN-α-2b SC on days 9 11 and 13
COURSES II-IV Patients receive recombinant fowlpox-CEA6D-TRICOM vaccine SC on day 1 Patients also receive GM-CSF as in course 1 and IFN-α-2b SC on days 1 3 and 5
NOTE The initial cohort of 6 patients does not receive IFN-α-2b
Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity After 4 courses patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA 6D-TRICOM vaccine GM-CSF and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years
Cohorts of 3-6 patients receive escalating doses of IFN-α-2b until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Six additional patients are treated at the MTD these patients must be HLA-A2 positive
After completion of study treatment patients are followed monthly for 4 months and then every 6-12 months for up to 15 years
I Determine the maximum tolerated dose and recommended phase II dose of interferon alfa-2b IFN-α-2b when administered with recombinant vaccinia-CEA6D-TRICOM vaccine recombinant fowlpox-CEA6D-TRICOM vaccine and sargramostim GM-CSF in patients with locally advanced or metastatic carcinoembryonic antigen CEA-expressing carcinoma
SECONDARY OBJECTIVES
I Determine the effect of IFN-α-2b on tumor cell expression of CEA and MHC class I antigens in patients treated with this regimen
II Determine the immunologic effects of this regimen in these patients III Determine any objective anti-tumor responses that may occur in response to this regimen in these patients
IV Determine the time to tumor progression in patients treated with this regimen
OUTLINE This is a dose-escalation study of interferon alfa-2b IFN-α-2b
COURSE I Patients receive recombinant vaccinia-CEA6D-TRICOM vaccine subcutaneously SC on day 1 Patients also receive sargramostim GM-CSF SC on days 1-4 and IFN-α-2b SC on days 9 11 and 13
COURSES II-IV Patients receive recombinant fowlpox-CEA6D-TRICOM vaccine SC on day 1 Patients also receive GM-CSF as in course 1 and IFN-α-2b SC on days 1 3 and 5
NOTE The initial cohort of 6 patients does not receive IFN-α-2b
Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity After 4 courses patients who do not have progressive disease or unacceptable toxicity may receive recombinant fowlpox-CEA 6D-TRICOM vaccine GM-CSF and IFN-α-2b every 28 days for 2 more courses and then every 3 months for up to 2 years
Cohorts of 3-6 patients receive escalating doses of IFN-α-2b until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Six additional patients are treated at the MTD these patients must be HLA-A2 positive
After completion of study treatment patients are followed monthly for 4 months and then every 6-12 months for up to 15 years
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 |
|---|---|---|---|
| NCI-5633 | None | None | None |
| NCI-2011-01347 | REGISTRY | None | None |
| OSU-2005H0005 | None | None | None |
| CDR0000439532 | None | None | None |
| 5633 | OTHER | None | None |
| P30CA016058 | NIH | None | None |
| OSU 0312 | OTHER | None | None |
| U01CA076576 | NIH | CTEP | httpsreporternihgovquickSearchU01CA076576 |