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Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma

NCT00512889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-03-01

No results posted yet for this study

Summary

RATIONALE: Cytotoxic T lymphocytes (CTL) are cells of the immune system that can fight infections and cancer. These CTL can be manipulated in the laboratory so that they can target an individual's cancer.

PURPOSE: This early phase trial is studying the feasibility and side effects of intravenous infusions of CTL generated in the laboratory. To produce the CTL, the study participant's own immune cells are collected by a procedure called a leukapheresis. The cells then undergo laboratory processing for three weeks. Part of this processing includes mixing the patients immune cells with a new kind of cell that has some extra genes added to it. These extra genes are to "teach" the participant's own immune cells to become anti-tumor CTL that can attack the melanoma.

Conditions

  • Melanoma (Skin)

Interventions

BIOLOGICAL

therapeutic autologous lymphocytes

Autologous CTL generated from peripheral blood following culture with MART1/Melan-A peptide pulsed aAPC.

GENETIC

Use of an artificial antigen presenting cell (aAPC) to generate CTL

A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.

DRUG

GM-CSF

GM-CSF will be used as an immune activator and combined with the infusion of MART1/Melan-A specific CTL.

RADIATION

Irradiation of cutaneous tumor lesion

Irradiation of cutaneous melanoma lesion will be combined with the infusion of MART1/Melan-A specific CTL.

Sponsors & Collaborators

Principal Investigators

  • Marcus Butler, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-02-28
Completion
2013-01-31

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00512889 on ClinicalTrials.gov