Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Combination of CTL with GMCSF +/- radiation

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

therapeutic autologous lymphocytes

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

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

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

GM-CSF

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

Irradiation of cutaneous tumor lesion

Marcus Butler, MD

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.

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.

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

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

Dana-Farber Cancer Institute

Instructor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma	NCT00512889	Melanoma (Skin)	therapeutic aut... Use of an artif... GM-CSF Irradiation of ...	18 Years -	Dana-Farber Cancer Institute
Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma	NCT00512889	Melanoma (Skin)	therapeutic aut... Use of an artif... GM-CSF Irradiation of ...	18 Years -	Dana-Farber Cancer Institute

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