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

Terminated

• Conditions: Melanoma; Kidney Cancer

• Registration Number: NCT01068470
• Lead Sponsor: Loma Linda University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Primary Completion: 2010-12
• Study Completion: 2012-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LAK cytotoxicity	4 months

Trial Locations

Locations (1)

Loma Linda University Cancer Center; 🇺🇸 Beaumont, California, United States