In Vitro Expanded Autologous Invariant Natural Killer Cells in Cancer

NCT00631072 | Completed Phase 1 DMC

• 1 other identifier: 06-432
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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 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

Keywords

iNKT; in vitro autologous iNKT

Outcome Measures

Primary Outcomes (2)

• To determine the feasibility of isolating and expanding in vitro autologous iNKT cells from cancer patients for therapeutic use.

  2 years

• To assess the safety of treatment with in vitro expanded autologous iNKT cells alone, and in conjunction with GM-CSF.

  2 years

Secondary Outcomes (2)

• To assess the biological activity of reinfused in vitro expanded autologous iNKT cells.

  2 years

• To assess the biological activity of reinfused in vitro expanded autologous iNKT cells in conjunction with GM-CSF.

  2 years

Study Arms (1)

GM-CSF +INKT

OTHER

INKT will be administered in 3 equal doses by intravenous infusion on days 1, 15 and 29. GM-CSF will be given subcutaneously once daily for 10 days beginning the second day of the second and third infusion

Biological: INKT; Drug: GM-CSF

Interventions

INKT BIOLOGICAL

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

Also known as: In vitro expanded autologous invariant natural killer T cells

GM-CSF +INKT

GM-CSF DRUG

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

GM-CSF +INKT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV melanoma
• ECOG Performance Status 0-1
• Estimated life expectancy of 6 months or greater
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Steven Balk, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• F. Stephen Hodi, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven Balk, MD

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: April 1, 2015
• Last Updated: June 9, 2017

Record last verified: 2017-06

Locations

US (2)