Determining the Lymphokine Activated Killer (LAK) Cytotoxicity Present in Patients Undergoing Interleukin-2 Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Loma Linda University
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
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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 May 16, 2013