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
1 other identifier
interventional
9
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 3, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 1, 2013
February 1, 2013
3.5 years
August 3, 2007
February 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Define the feasibility of generating large doses of MART1/Melan-A specific CTL following leukapheresis in this patient population
2 years
Describe the toxicity of two dose levels of adoptively transferred MART1/Melan-A specific CTL lines
2 years
Define the feasibility of combining the infusion of MART1/Melan-A specific CTL with the administration of GM-CSF +/- radiotherapy
2 years
Describe the toxicity of combining the infusion of MART1/Melan-A specific CTL with the administration of GM-CSF +/- radiotherapy
2 years
Secondary Outcomes (1)
Evaluate function, phenotype, and trafficking of infused CTL.
2 years
Study Arms (3)
Cohort 1
EXPERIMENTALDifferent dose of CTL
Cohort 2
EXPERIMENTALDifferent dose of CTL
Cohort 3
EXPERIMENTALCombination of CTL with GMCSF +/- radiation
Interventions
Autologous CTL generated from peripheral blood following culture with MART1/Melan-A peptide pulsed aAPC.
A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
GM-CSF will be used as an immune activator and combined with the infusion of MART1/Melan-A specific CTL.
Irradiation of cutaneous melanoma lesion will be combined with the infusion of MART1/Melan-A specific CTL.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Related Publications (1)
Butler MO, Friedlander P, Milstein MI, Mooney MM, Metzler G, Murray AP, Tanaka M, Berezovskaya A, Imataki O, Drury L, Brennan L, Flavin M, Neuberg D, Stevenson K, Lawrence D, Hodi FS, Velazquez EF, Jaklitsch MT, Russell SE, Mihm M, Nadler LM, Hirano N. Establishment of antitumor memory in humans using in vitro-educated CD8+ T cells. Sci Transl Med. 2011 Apr 27;3(80):80ra34. doi: 10.1126/scitranslmed.3002207.
PMID: 21525398RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Butler, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
August 3, 2007
First Posted
August 8, 2007
Study Start
August 1, 2007
Primary Completion
February 1, 2011
Study Completion
January 1, 2013
Last Updated
March 1, 2013
Record last verified: 2013-02