Adoptive Transfer of MART1/Melan-A CTL for Malignant Melanoma
NCT ID: NCT00512889
Last Updated: 2013-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2007-08-31
2013-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
Different dose of CTL
therapeutic autologous lymphocytes
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
A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
Cohort 2
Different dose of CTL
therapeutic autologous lymphocytes
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
A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
Cohort 3
Combination of CTL with GMCSF +/- radiation
therapeutic autologous lymphocytes
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
A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
GM-CSF
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
Irradiation of cutaneous melanoma lesion will be combined with the infusion of MART1/Melan-A specific CTL.
Interventions
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therapeutic autologous lymphocytes
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
A genetically modified artificial antigen presenting cell (aAPC) is used in the generation of anti-tumor CTL.
GM-CSF
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
Irradiation of cutaneous melanoma lesion will be combined with the infusion of MART1/Melan-A specific CTL.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Marcus O. Butler, MD
Instructor
Principal Investigators
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Marcus Butler, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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06-250
Identifier Type: -
Identifier Source: org_study_id
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