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NCT01068470 Clinical Trial

Determining the Lymphokine Activated Killer (LAK) Cytotoxicity Present in Patients Undergoing Interleukin-2 Therapy

Melanoma Clinical Trial

— LAK  

Official title:
Lymphokine Activated Killer (LAK) Cell Activity Against Cell Lines In-vitro of LAK Generated in Vivo by Pulse Interleukin-2 Therapy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01068470
Other study ID # 59210
Secondary ID
Status Terminated
Phase N/A
First received February 11, 2010
Last updated May 28, 2014
Start date November 2009
Est. completion date March 2012

Study information
Verified date May 2014
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Therapy with Interleukin-2 stimulates lymphocytes in humans to become Lymphokine-activated Killer cells (LAK). This study will determine if these killer cells are able to kill certain standard cell-lines in the laboratory.

Description:

Blood samples will be taken from patients undergoing outpatient Interleukin-2 therapy to measure the LAK cytotoxicity at baseline, after 1 cycle of therapy and 2 months later. The LAK cytotoxicity assay will be a standard colorimetric assay that measures lactic dehydrogenase release from lysed cells.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date March 2012
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must be undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center

- Patients must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

- Patients not undergoing Interleukin-2 therapy under the care of physicians at Loma Linda University Cancer Center

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Loma Linda University Cancer Center Beaumont California

Sponsors (1)
Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary LAK cytotoxicity 4 months No
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