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In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer

NCT00631072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-06-09

No results posted yet for this study

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 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.

Conditions

  • Malignant Melanoma

Interventions

BIOLOGICAL

INKT

Administered in 3 equal doses by intravenous infusion on days 1, 15 and 29.

DRUG

GM-CSF

Given subcutaneously once daily for 10 days beginning the second day of the second and third infusion

Sponsors & Collaborators

Principal Investigators

  • Steven Balk, MD, PhD · Beth Israel Deaconess Medical Center

  • F. Stephen Hodi, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-08-31
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631072 on ClinicalTrials.gov