Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002505
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
1999-11-01
Brief Title:
Tumor Cell Vaccine in Treating Patients With Advanced Cancer
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
RANDOMIZED PHASE II TRIAL OF AUTOLOGOUS TUMOR CELL VACCINE
Status:
COMPLETED
Status Verified Date:
2011-05
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 made from the patients cancer cells may make the body build an immune response and kill their tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of autologous tumor cell vaccination plus immunologic adjuvant in treating patients who have metastatic cancer
PURPOSE Randomized phase II trial to study the effectiveness of autologous tumor cell vaccination plus immunologic adjuvant in treating patients who have metastatic cancer
Detailed Description:
OBJECTIVES I Determine the toxic effects and side effects associated with administration of autologous tumor cell vaccine together with adjuvant interferon gamma or sargramostim GM-CSF in patients with advanced cancer II Determine the rate of conversion of delayed tumor hypersensitivity in patients receiving subcutaneous injections of irradiated autologous tumor cells autologous vaccine III Determine the effect of autologous vaccines on in vitro assays of immune antitumor activity IV Determine the failure free survival associated with the use of autologous tumor cell line vaccines in patients with advanced cancer
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center tumor type disease stage remission status complete vs partial prior therapy progressive disease yes vs no and performance status ECOG 0-1 vs 2 Patients are randomized into one of two treatment arms Arm I Patients receive vaccination with irradiated autologous tumor cells subcutaneously SQ on week 1 and then autologous tumor cell vaccine plus interferon gamma SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week 24 Arm II Patients receive vaccination with irradiated autologous tumor cells as in arm I and then autologous tumor cell vaccine plus sargramostim GM-CSF SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week 24
PROJECTED ACCRUAL A total of 20-30 patients from each major tumor type breast lung prostate colorectal sarcoma renal melanoma will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center tumor type disease stage remission status complete vs partial prior therapy progressive disease yes vs no and performance status ECOG 0-1 vs 2 Patients are randomized into one of two treatment arms Arm I Patients receive vaccination with irradiated autologous tumor cells subcutaneously SQ on week 1 and then autologous tumor cell vaccine plus interferon gamma SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week 24 Arm II Patients receive vaccination with irradiated autologous tumor cells as in arm I and then autologous tumor cell vaccine plus sargramostim GM-CSF SQ on weeks 2 and 3 and then monthly beginning on week 8 and continuing until week 24
PROJECTED ACCRUAL A total of 20-30 patients from each major tumor type breast lung prostate colorectal sarcoma renal melanoma 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-V92-0155 | None | None | None |
| CBRG-9212 | None | None | None |
| NBSG-9212 | None | None | None |