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ACTIVE NOT RECRUITING
NCT01955460
PHASE1

Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2014-10-15

Completion Date

2027-10-30

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

Aldesleukin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

NGFR-transduced Autologous T Lymphocytes

Given IV

BIOLOGICAL

TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes

Given IV

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States