Ignite Creation Date:
2024-05-06 @ 2:01 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01955460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2013-09-27
Brief Title:
Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients with Stage III-IV Melanoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer with TGF-Beta Resistant DNRII and NGFR Transduced T-Cells Followed by High Dose Interleukin-2 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:
This pilot phase I trial studies the side effects and best dose of genetically modified T-cells followed by aldesleukin in treating patients with stage III-IV melanoma T-cells are a type of white blood cell that help the body fight infections Genes that may help the T-cells recognize melanoma cells are placed into the T-cells in the laboratory Adding these genes to the T cells may help them kill more tumor cells when they are put back in the body Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells
Detailed Description:
PRIMARY OBJECTIVES
Primary for Cohort A
I To assess the feasibility and safety of autologous transforming growth factor beta TGFb resistant DNRII transduced and NGFR transduced tumor infiltrating lymphocytes TIL in patients with metastatic melanoma
Primary for Cohort B
I To assess the feasibility and safety of autologous TGBβ resistant DNRII transduced TIL in patients with metastatic melanoma Feasibility will be defined as the production of virally transduced T cells and treatment of patients with these cells
SECONDARY OBJECTIVES
Secondary for Cohort A
I To determine the survival and immune function of TGFb resistant DNRII transduced TIL in vivo
II To assess the anti-tumor effects of TGFb resistant DNRII transduced TIL
Secondary for Cohort B
I To determine the survival and immune function of TGFβ resistant DNRII transduced TIL in vivo
II To assess the anti-tumor effects of TGFβ resistant DNRII transduced TIL
OUTLINE
Patients receive cyclophosphamide intravenously IV over 2 hours on days -7 and -6 fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1 and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0 Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 up to 15 doses and 22-26 up to 15 doses
After completion of study treatment patients are followed up at 6 and 12 weeks every 3 months for 1 year and then yearly for 10 years
Primary for Cohort A
I To assess the feasibility and safety of autologous transforming growth factor beta TGFb resistant DNRII transduced and NGFR transduced tumor infiltrating lymphocytes TIL in patients with metastatic melanoma
Primary for Cohort B
I To assess the feasibility and safety of autologous TGBβ resistant DNRII transduced TIL in patients with metastatic melanoma Feasibility will be defined as the production of virally transduced T cells and treatment of patients with these cells
SECONDARY OBJECTIVES
Secondary for Cohort A
I To determine the survival and immune function of TGFb resistant DNRII transduced TIL in vivo
II To assess the anti-tumor effects of TGFb resistant DNRII transduced TIL
Secondary for Cohort B
I To determine the survival and immune function of TGFβ resistant DNRII transduced TIL in vivo
II To assess the anti-tumor effects of TGFβ resistant DNRII transduced TIL
OUTLINE
Patients receive cyclophosphamide intravenously IV over 2 hours on days -7 and -6 fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1 and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0 Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 up to 15 doses and 22-26 up to 15 doses
After completion of study treatment patients are followed up at 6 and 12 weeks every 3 months for 1 year and then yearly for 10 years
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 |
|---|---|---|---|
| NCI-2014-01211 | REGISTRY | None | None |
| RP110553-P4 | None | None | None |
| 2012-0758 | OTHER | M D Anderson Cancer Center | None |
| RM1012-012-1 | None | None | None |