Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085462
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2004-06-10
Brief Title:
Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Patients With Metastatic Melanoma by Lymphodepleting Conditioning Followed by Infusion of TCR-Gene Engineered Lymphocytes and Subsequent Fowlpox gp100 Vaccination
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Inserting a gene that has been created in the laboratory into a persons white blood cells may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Vaccines may make the body build an immune response to kill tumor cells Combining gene-modified white blood cell infusions with interleukin-2 and vaccine therapy may kill more tumor cells
PURPOSE This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works in treating patients with metastatic melanoma
PURPOSE This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine preliminarily any clinical tumor regression in lymphodepleted patients with metastatic melanoma treated with fowlpox gp100 antigen immunization and antitumor antigen T-cell receptor TCR-engineered tumor infiltrating lymphocytes or CD8 autologous peripheral blood lymphocytes followed by interleukin-2
Secondary
Determine the in vivo survival of TCR gene-engineered cells in patients treated with this regimen
OUTLINE Patients are stratified according to their ability to produce tumor-infiltrating lymphocytes TIL yes vs no
Patients receive lymphodepleting chemotherapy comprising cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1
Stratum 1 TIL Patients receive TIL retrovirally transduced with gp100 antigen TCR gene IV over 20-30 minutes on day 0
Stratum 2 CD8peripheral blood lymphocytes PBL Patients receive CD8PBL retrovirally transduced with gp100 antigen TCR gene IV over 20-30 minutes on day 0
NOTE Day 0 is 1-4 days after the last dose of fludarabine
Patients in both strata also receive fowlpox-gp100 vaccine before TILPBL infusion IV over 1-2 minutes on days 0 and 28 and high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours on days 0-4 and days 28-32 Patients also receive G-CSF SC once daily beginning on day 0 and continuing until blood counts recover
Treatment continues in the absence of disease progression or unacceptable toxicity Beginning 6-8 weeks after the last dose of vaccine and high-dose IL-2 patients with stable or responding disease may receive 1 retreatment course
Responding patients are followed at 1 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 61 patients will be accrued for this study
Primary
Determine preliminarily any clinical tumor regression in lymphodepleted patients with metastatic melanoma treated with fowlpox gp100 antigen immunization and antitumor antigen T-cell receptor TCR-engineered tumor infiltrating lymphocytes or CD8 autologous peripheral blood lymphocytes followed by interleukin-2
Secondary
Determine the in vivo survival of TCR gene-engineered cells in patients treated with this regimen
OUTLINE Patients are stratified according to their ability to produce tumor-infiltrating lymphocytes TIL yes vs no
Patients receive lymphodepleting chemotherapy comprising cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1
Stratum 1 TIL Patients receive TIL retrovirally transduced with gp100 antigen TCR gene IV over 20-30 minutes on day 0
Stratum 2 CD8peripheral blood lymphocytes PBL Patients receive CD8PBL retrovirally transduced with gp100 antigen TCR gene IV over 20-30 minutes on day 0
NOTE Day 0 is 1-4 days after the last dose of fludarabine
Patients in both strata also receive fowlpox-gp100 vaccine before TILPBL infusion IV over 1-2 minutes on days 0 and 28 and high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours on days 0-4 and days 28-32 Patients also receive G-CSF SC once daily beginning on day 0 and continuing until blood counts recover
Treatment continues in the absence of disease progression or unacceptable toxicity Beginning 6-8 weeks after the last dose of vaccine and high-dose IL-2 patients with stable or responding disease may receive 1 retreatment course
Responding patients are followed at 1 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 61 patients 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 |
|---|---|---|---|
| CDR0000370798 | None | None | None |
| 04-C-0181 | None | None | None |
| NCI-6470 | None | None | None |