Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070070
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2003-10-03
Brief Title:
Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas
Sponsor:
Ludwig Institute for Cancer Research
Organization:
Ludwig Institute for Cancer Research
Study Overview
Official Title:
NY-ESO-1 Protein Immunization of Post-Cystectomy or Post-Nephroureterectomy Patients With Transitional Cell Carcinomas
Status:
COMPLETED
Status Verified Date:
2022-10
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 peptides may make the body build an immune response to kill tumor cells Biological therapies such as Bacille Calmette Guerin BCG and sargramostim GM-CSF use different ways to stimulate the immune system and stop tumor cells from growing Combining vaccine therapy with biological therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas
PURPOSE This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of NY-ESO-1 peptide vaccine Bacille Calmette Guerin BCG and sargramostim GM-CSF in post-cystectomy patients with transitional cell carcinoma of the bladder expressing NY-ESO-1 or LAGE-1 antigen
Determine the immunological profile NY-ESO-1 antibody CD8 cells and delayed-type hypersensitivity induced by this regimen in these patients
OUTLINE This is an open-label pilot study
Patients receive NY-ESO-1 protein vaccine mixed with BCG intradermally ID once weekly on weeks 1 and 2 Patients then receive NY-ESO-1 protein mixed with sargramostim GM-CSF ID once weekly on day 2 of weeks 3-6 Patients also receive GM-CSF subcutaneously alone on days 1 3 4 and 5 of weeks 3-6
Determine the safety and tolerability of NY-ESO-1 peptide vaccine Bacille Calmette Guerin BCG and sargramostim GM-CSF in post-cystectomy patients with transitional cell carcinoma of the bladder expressing NY-ESO-1 or LAGE-1 antigen
Determine the immunological profile NY-ESO-1 antibody CD8 cells and delayed-type hypersensitivity induced by this regimen in these patients
OUTLINE This is an open-label pilot study
Patients receive NY-ESO-1 protein vaccine mixed with BCG intradermally ID once weekly on weeks 1 and 2 Patients then receive NY-ESO-1 protein mixed with sargramostim GM-CSF ID once weekly on day 2 of weeks 3-6 Patients also receive GM-CSF subcutaneously alone on days 1 3 4 and 5 of weeks 3-6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| MSKCC-03047 | OTHER | None | None |
| LUDWIG-LUD2002-004 | OTHER | None | None |
| CDR0000329920 | OTHER | Ludwig Institute for Cancer Research | None |