Status:
COMPLETED
In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine whether we can purify and grow a population of cells from the participants blood (iNKT cells) and then safely give them back to the participant in in...
Detailed Description
* The first step in the study will be to collect iNKT cells from the participants peripheral blood. For this procedure an intravenous catheter will be used to remove the blood. The white blood cells w...
Eligibility Criteria
Inclusion
- Stage IV melanoma
- ECOG Performance Status 0-1
- Estimated life expectancy of 6 months or greater
- 18 years of age or older
- Adequate renal, hepatic and hematological function as outlined in protocol
- Adequate pulmonary and cardiac function as outlined in protocol
- Prior therapies must be discontinued at least 4 weeks prior to the leukopheresis to obtain iNKT cells. This does not include palliative surgery or radiation therapy, which may be used prior to leukopheresis or during the interval between leukopheresis and iNKT cell reinfusion
- Melanoma patients must not have brain metastases based on a negative MRI obtained within 4 weeks prior to screening, and must not have a history of brain metastases
- No other significant medical, surgical or psychiatric condition that, in the judgment of the PI, would interfere with compliance to the protocol regimen
Exclusion
- Pregnant or nursing women
- Active systemic infection, positive HIV, HBV, or HCV serology, or immune deficiency disease
- Autoimmune disease that currently requires systemic therapy with immunosuppressive agents
- Known hypersensitivity to GM-CSF or DMSO
- Other active malignancy other than squamous cell or basal cell of the skin
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00631072
Start Date
February 1 2008
End Date
April 1 2015
Last Update
June 9 2017
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115