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

May 28, 2014 updated by: Loma Linda University

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

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beaumont, California, United States, 92223
        • Loma Linda University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with melanoma or kidney cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LAK cytotoxicity
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Walter Quan, MD, Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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