Vemurafenib With Lymphodepletion Plus Adoptive Cell Transfer & High Dose IL-2 Metastatic Melanoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

August 3, 2012

Primary Completion Date

October 6, 2021

Study Completion Date

September 30, 2025

Conditions
Metastatic Melanoma
Interventions
DRUG

High Dose Interleukin-2 (IL-2)

A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.

PROCEDURE

ACT with TIL Infusion

Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).

DRUG

Vemurafenib

Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.

DRUG

Lymphodepletion

"The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more space for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion."

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER