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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Loma Linda University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01068470
First received: February 11, 2010
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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.


Condition
Melanoma
Kidney Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lymphokine Activated Killer (LAK) Cell Activity Against Cell Lines In-vitro of LAK Generated in Vivo by Pulse Interleukin-2 Therapy

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • LAK cytotoxicity [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2009
Estimated Study Completion Date: September 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with melanoma or kidney cancer

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068470

Locations
United States, California
Loma Linda University Cancer Center
Beaumont, California, United States, 92223
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Walter Quan, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01068470     History of Changes
Other Study ID Numbers: 59210
Study First Received: February 11, 2010
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Interleukin-2
Melanoma
Kidney Cancer
Lymphokine Activated Killer cells

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Melanoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014