Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512889
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2007-08-03
Brief Title:
Adoptive Transfer of MART1Melan-A CTL for Malignant Melanoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Pilot Study of the Adoptive Transfer of MART1Melan-A CTL for Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 individuals 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 participants 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 participants own immune cells to become anti-tumor CTL that can attack the melanoma
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 participants 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 participants own immune cells to become anti-tumor CTL that can attack the melanoma
Detailed Description:
DETAILED OUTLINE This is an early phase pilotfeasibility 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None