In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer

Completed · Phase 1

Conditions studied: Malignant Melanoma

In brief

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 increased numbers, and whether these cells will then stimulate the bodies own immune response against the cancer. These iNKT cells have been used in laboratory studies and information from these and other research studies suggest that increasing the number of these cells in the blood can stimulate the immune response against tumors.

Key facts

Study ID

NCT00631072

Run by

Beth Israel Deaconess Medical Center

People needed

9

Starts

2008-02-01

Expected to finish

2015-04-01

Last updated by the study team

2017-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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