Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028496
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2002-01-04
Brief Title:
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of a Recombinant Fowl Pox Vaccine rF-CEA 6DTRICOM Alone or With GM-CSF in Patients With Advanced CEA Expressing Adenocarinomas
Status:
COMPLETED
Status Verified Date:
2013-01
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 study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have advanced or metastatic cancer Vaccines may make the body build an immune response to kill tumor cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Combining vaccine therapy with sargramostim may make tumor cells more sensitive to the vaccine and may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the toxicity of recombinant fowlpox-CEA-TRICOM vaccine with or without sargramostim GM-CSF or recombinant fowlpox-GM-CSF in patients with advanced or metastatic CEA-expressing adenocarcinomas
II Determine the CEA-specific T-cell precursor frequency in patients treated with these regimens
III Assess the immunogenicity of GM-CSF in patients treated with these regimens
IV Determine the inflammatory response and cytokine expression at the vaccination site in these patients 48 hours after vaccination
V Correlate telomere length of leukocytes with prior cytotoxic therapies and immunologic response in patients treated with these regimens
OUTLINE This is a dose-escalation study The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine fCEA-TRI until the maximum tolerated dose MTD is determined
The MTD is defined as the dose preceding that at which 2 of 6 patients or 3 of 12 patients experience dose-limiting toxicity fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter beginning on day 56 in the absence of disease progression or unacceptable toxicity
The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim GM-CSF GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days
The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF rF-GM-CSF rF-GM-CSF is administered in the same manner as GM-CSF
Patients are followed every month for 4 months
I Determine the toxicity of recombinant fowlpox-CEA-TRICOM vaccine with or without sargramostim GM-CSF or recombinant fowlpox-GM-CSF in patients with advanced or metastatic CEA-expressing adenocarcinomas
II Determine the CEA-specific T-cell precursor frequency in patients treated with these regimens
III Assess the immunogenicity of GM-CSF in patients treated with these regimens
IV Determine the inflammatory response and cytokine expression at the vaccination site in these patients 48 hours after vaccination
V Correlate telomere length of leukocytes with prior cytotoxic therapies and immunologic response in patients treated with these regimens
OUTLINE This is a dose-escalation study The first three cohorts of 3-12 patients receive escalating doses of recombinant fowlpox-CEA-TRICOM vaccine fCEA-TRI until the maximum tolerated dose MTD is determined
The MTD is defined as the dose preceding that at which 2 of 6 patients or 3 of 12 patients experience dose-limiting toxicity fCEA-TRI is administered intradermally every 2 weeks for 4 doses and then every 2 months thereafter beginning on day 56 in the absence of disease progression or unacceptable toxicity
The fourth and fifth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of sargramostim GM-CSF GM-CSF is administered subcutaneously once daily beginning on the day of each vaccination and continuing for a total of 4 days
The sixth through eighth cohorts of 6 patients receive fCEA-TRI at the MTD in the same manner as the first three cohorts combined with escalating doses of recombinant fowlpox-GM-CSF rF-GM-CSF rF-GM-CSF is administered in the same manner as GM-CSF
Patients are followed every month for 4 months
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 |
|---|---|---|---|
| FCCC-01016 | None | None | None |
| CDR0000069093 | REGISTRY | PDQ Physician Data Query | None |