Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

1,230

Participants

Timeline

Start Date

February 1, 2006

Primary Completion Date

February 28, 2030

Study Completion Date

February 28, 2030

Conditions
Melanoma
Interventions
BIOLOGICAL

Dendritic Cell Immunization

1x10\^7 to 2.5x10\^8 MART-1 peptide-pulsed Dendritic Cells given by vein over 20-30 minutes approximately 4 hrs after receiving T cells.

DRUG

Cyclophosphamide

60 mg/kg/d by vein over 2 hours on Days -7 and -6 before T cell infusion

DRUG

Fludarabine

25 mg/m\^2 by vein daily over 30 minutes on Days -5 to -1 before T cell infusion.

BIOLOGICAL

T-Cells

On Days 0, up to 1.5 x 10\^11 T-cells by vein infusion over 30-60 minutes.

BIOLOGICAL

Interleukin-2

12-16 hours after completing the T cell infusion, all will receive high dose IL-2 on an inpatient basis at the standard dose of 720,000 IU/kg as an intravenous bolus over approximately a 15 minute period every 8-16 hours for up to 15 doses on Days 1-5 and 22-26 (+/- 7 days), as tolerated.

DRUG

Mesna

60 mg/kg with D5W or NS at 125 ml/hr infused intravenously over 24 hours on Day -7 and -6.

BIOLOGICAL

Intrathecal T-Cells

5.0x10\^9 T-cells administered on Day 1, and 10x10\^9 T-cells on Day 15. 1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated.

BIOLOGICAL

Intrathecal Interleukin-2

1.2 MIU of IL- 2 on Day 2, 4, 9, 11, 16 and 18 as tolerated. Then, patient receives twice weekly IL-2 that will be gradually changed to weekly IL-2. After 4-6 weeks patients switched to IL-2 maintenance.

Trial Locations (1)

77030

The University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Prometheus Laboratories

INDUSTRY

collaborator

Key Biologics, LLC

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Adelson Medical Research

UNKNOWN

lead

M.D. Anderson Cancer Center

OTHER