Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003125
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
1999-11-01
Brief Title:
Vaccine Therapy Interleukin-2 and Sargramostim in Treating Patients With Advanced Tumors
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Pilot Study of Sequential Vaccinations With ALVAC-CEA and Vaccinia-CEA With the Addition of IL-2 and GM-CSF in Patients With CEA Expressing Tumors
Status:
COMPLETED
Status Verified Date:
2007-05
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:
RATIONALE 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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Combining vaccine therapy sargramostim and interleukin-2 may kill more cancer cells
PURPOSE Randomized phase II trial to study the effectiveness of vaccine therapy sargramostim and interleukin-2 in treating patients who have advanced tumors
PURPOSE Randomized phase II trial to study the effectiveness of vaccine therapy sargramostim and interleukin-2 in treating patients who have advanced tumors
Detailed Description:
OBJECTIVES I Evaluate the safety of sequentially administered vaccinia-carcinoembryonic antigen CEA vaccine and ALVAC-CEA vaccine CEA-Avipox vaccine in two schedules and with the addition of sargramostim GM-CSF plus or minus interleukin-2 IL-2 in patients with CEA expressing tumors II Compare the CEA-specific cellular immune response in cancer patients randomized to receive a single vaccination with vaccinia-CEA vaccine followed by three boosts with ALVAC-CEA vaccine V-A-A-A or the reverse vaccination sequence A-A-A-V III Determine whether the addition of GM-CSF alone or with IL-2 enhances the immune response to sequentially administered vaccinia-CEA vaccine and ALVAC-CEA vaccine IV Compare the enzyme linked immunosorbent assay ELISPOT with lymphoproliferative and cytotoxicity assays for measuring CEA-specific T lymphocyte immune response
OUTLINE This is two-stage partially randomized study In stage one patients are randomized to arm I or II Arm I Patients receive vaccinia-carcinoembryonic antigen CEA vaccine intradermally on day 1 of course 1 and ALVAC-CEA vaccine CEA-Avipox vaccine intramuscularly IM on day 1 of courses 2-4 Each course lasts 28 days Arm II Patients receive ALVAC-CEA vaccine CEA-Avipox vaccine IM on day 1 of courses 1-3 and vaccinia-CEA vaccine intradermally on day 1 of course 4 Each course lasts 28 days Patients in arms I and II continue 28-day courses through month 6 and then receive 3-month courses for 2 years in the absence of disease progression or unacceptable toxicity In stage two patients are enrolled successively into arms III and IV Arm III Patients receive vaccines according to whichever schedule arm I or II was found to be superior plus sargramostim GM-CSF subcutaneously SC on days 1-4 of each course Each course lasts 28 days Arm IV Patients receive vaccines plus GM-CSF as in arm III and interleukin-2 SC once daily on days 7-11 of each course Each course lasts 28 days Patients on arms III and IV continue 28-day courses through month 6 and then receive 3-month courses for 2 years in the absence of disease progression or unacceptable toxicity If 2 or more patients in either arm III or IV experience dose limiting toxicity accrual into study stops Otherwise the best response among the 4 arms is determined and further HLA-A2 positive patients are enrolled into that arm so that a total of 6 HLA-A2 positive patients with advanced disease and 6 HLA-A2 positive patients with NED without radiographic or clinical evidence of tumor are treated If more than one regimen is equally superior the least toxic regimen is chosen for further accrual Patients are followed at 28 days following the last vaccination
PROJECTED ACCRUAL A minimum of 24 patients 6 HLA-A2 positive and up to 3 HLA-A2 negative patients per arm will be accrued for this study
OUTLINE This is two-stage partially randomized study In stage one patients are randomized to arm I or II Arm I Patients receive vaccinia-carcinoembryonic antigen CEA vaccine intradermally on day 1 of course 1 and ALVAC-CEA vaccine CEA-Avipox vaccine intramuscularly IM on day 1 of courses 2-4 Each course lasts 28 days Arm II Patients receive ALVAC-CEA vaccine CEA-Avipox vaccine IM on day 1 of courses 1-3 and vaccinia-CEA vaccine intradermally on day 1 of course 4 Each course lasts 28 days Patients in arms I and II continue 28-day courses through month 6 and then receive 3-month courses for 2 years in the absence of disease progression or unacceptable toxicity In stage two patients are enrolled successively into arms III and IV Arm III Patients receive vaccines according to whichever schedule arm I or II was found to be superior plus sargramostim GM-CSF subcutaneously SC on days 1-4 of each course Each course lasts 28 days Arm IV Patients receive vaccines plus GM-CSF as in arm III and interleukin-2 SC once daily on days 7-11 of each course Each course lasts 28 days Patients on arms III and IV continue 28-day courses through month 6 and then receive 3-month courses for 2 years in the absence of disease progression or unacceptable toxicity If 2 or more patients in either arm III or IV experience dose limiting toxicity accrual into study stops Otherwise the best response among the 4 arms is determined and further HLA-A2 positive patients are enrolled into that arm so that a total of 6 HLA-A2 positive patients with advanced disease and 6 HLA-A2 positive patients with NED without radiographic or clinical evidence of tumor are treated If more than one regimen is equally superior the least toxic regimen is chosen for further accrual Patients are followed at 28 days following the last vaccination
PROJECTED ACCRUAL A minimum of 24 patients 6 HLA-A2 positive and up to 3 HLA-A2 negative patients per arm 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 |
|---|---|---|---|
| NCI-T97-0033 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |
| U01CA062500 | NIH | None | None |
| P30CA051008 | NIH | None | None |
| GUMC-97118 | None | None | None |