Skip to main content
OpenTrials
Completed

NCT Number: NCT00512889

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma (Skin) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

DETAILED OUTLINE: This is an early phase pilot/feasibility trial.

Study subjects will be sequentially accrued to three cohorts. Cohorts 1 and 2 will evaluate the safety and feasibility of infusing two different doses of CTL.

  • Participants in all cohorts will undergo two CTL infusions 5 weeks apart.
  • Procedures performed during the trial will include physical examinations, laboratory tests, delayed hypersensitivity testing, and skin biopsies.
  • Between 5 and 8 days after the first CTL infusion, a biopsy or excision of a melanoma lesion may be performed.
  • Three leukapheresis procedures will be performed: two to collect peripheral blood for CTL production and one for research purposes at the end of the clinical trial.
  • Radiology tests (including CT scans) will be performed prior to infusion and about 4-5 weeks after the second CTL infusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with metastatic melanoma: Either unresectable Stage III or any Stage IV
  • ECOG of 0 or 1
  • HLA-A*0201 haplotype
  • Baseline tumor biopsy MART1/Melan-A expression present (in >10% of tumor cells)
  • Patient provides consent for all required biopsies
  • Adequate intravenous access for leukapheresis
  • Absolute lymphocyte count >500/ul at least once within 30 days of leukapheresis
  • Life expectancy greater than 4 months in the opinion of the study clinician
  • Negative pregnancy test

Exclusion criteria

  • Administration of systemic corticosteroids within 28 days of planned leukapheresis
  • Administration of cytotoxic chemotherapy or anti-tumor immunotherapy within 28 days of planned leukapheresis
  • Administration of radiotherapy within 28 days of planned leukapheresis with the exception of subjects accrued to Cohort 3
  • Active autoimmunity requiring systemic immunosuppressive therapy
  • HIV infection
  • Previous enrollment on this protocol and infusion of MART1/Melan-A CTL

Treatment and study plan

therapeutic autologous lymphocytes

Biological

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

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

Genetic

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

GM-CSF

Drug

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

Irradiation of cutaneous tumor lesion

Radiation

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

Primary outcomes

  1. Define the feasibility of generating large doses of MART1/Melan-A specific CTL following leukapheresis in this patient population

    Time frame: 2 years

  2. Describe the toxicity of two dose levels of adoptively transferred MART1/Melan-A specific CTL lines

    Time frame: 2 years

  3. Define the feasibility of combining the infusion of MART1/Melan-A specific CTL with the administration of GM-CSF +/- radiotherapy

    Time frame: 2 years

  4. Describe the toxicity of combining the infusion of MART1/Melan-A specific CTL with the administration of GM-CSF +/- radiotherapy

    Time frame: 2 years

Secondary outcomes

  1. Evaluate function, phenotype, and trafficking of infused CTL.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Aug 8, 2007
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.