Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma
Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2
2 other identifiers
observational
15
1 country
1
Brief Summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at biomarkers that predict response to high-dose aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2007
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 16, 2010
CompletedOctober 10, 2023
October 1, 2023
1.4 years
February 15, 2008
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2) from blood draws at baseline, prior to course 2 and 4 weeks after course 2
10 weeks
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2 from blood draws at baseline, prior to course 2 and 4 weeks after course 2
10 weeks
Frequency of mutations on genes encoding IL-2 receptor A and B
Frequency of mutations on genes encoding IL-2 receptor A and B from blood draws at baseline, prior to course 2 and 4 weeks after course 2
10 weeks
Interventions
Eligibility Criteria
Subjects will be receiving HD IL-2.
You may qualify if:
- Diagnosis of metastatic renal cell carcinoma or metastatic melanoma
- Must be receiving treatment with high-dose aldesleukin as part of standard therapy
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Nebraska Medical Center, Eppley Cancer Center
Omaha, Nebraska, 68198-6805, United States
Biospecimen
Blood samples will be collected prior to, at mid-course and at the end of the course of IL-2 therapy.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Hauke, MD
University of Nebraska
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 18, 2008
Study Start
October 2, 2007
Primary Completion
February 18, 2009
Study Completion
April 16, 2010
Last Updated
October 10, 2023
Record last verified: 2023-10