Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338377
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-07
First Post:
2006-02-10
Brief Title:
Lymphodepletion Plus Adoptive Cell Transfer with or Without Dendritic Cell Immunization in Patients with Metastatic Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Lymphodepletion Plus Adoptive Cell Transfer with or Without Dendritic Cell Immunization in Patients with Metastatic Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Objectives
The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 Cohort A have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone
Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability to migrate to the tumor site In addition we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo
Additionally secondary objectives will include correlation of clinical parameters with survival overall survival and progression-free survival for all cohorts
COHORT C
In a separate cohort Cohort C the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone
COHORT D
The primary objective of Cohort D is to confirm the safety of adoptively transferred TIL into the CSF
The secondary objective is the evaluation of clinical imaging and CSF response Correlative objectives will assess if the intrathecally-infused T cells persist in the CSF assess circulating tumor cells in the CSF and assess various cytokine and other analysesas feasible
COHORT E
The primary objective of Cohort E is to determine the overall response rate of TIL treatment with cells grown by the TIL 30 pre-REP Turnstile 1 phase of cellular growth
The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 Cohort A have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone
Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability to migrate to the tumor site In addition we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo
Additionally secondary objectives will include correlation of clinical parameters with survival overall survival and progression-free survival for all cohorts
COHORT C
In a separate cohort Cohort C the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone
COHORT D
The primary objective of Cohort D is to confirm the safety of adoptively transferred TIL into the CSF
The secondary objective is the evaluation of clinical imaging and CSF response Correlative objectives will assess if the intrathecally-infused T cells persist in the CSF assess circulating tumor cells in the CSF and assess various cytokine and other analysesas feasible
COHORT E
The primary objective of Cohort E is to determine the overall response rate of TIL treatment with cells grown by the TIL 30 pre-REP Turnstile 1 phase of cellular growth
Detailed Description:
None
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 |
|---|---|---|---|
| 5R01CA187076-02 | NIH | NCI CTRP | httpsreporternihgovquickSearch5R01CA187076-02 |
| NCI-2012-01368 | REGISTRY | None | None |