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Clinical trial

Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2

ID
Name
0278-07-FB
Description
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 arms
Trial start
2007-10-02
Estimated PCD
2009-02-18
Trial end
2010-04-16
Status
Completed
Treatment
aldesleukin
gene expression analysis
mutation analysis
flow cytometry
Size
15
Primary endpoint
Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
10 weeks
Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
10 weeks
Frequency of mutations on genes encoding IL-2 receptor A and B
10 weeks
Eligibility criteria
Inclusion Criteria: * Diagnosis of metastatic renal cell carcinoma or metastatic melanoma * Must be receiving treatment with high-dose aldesleukin as part of standard therapy Exclusion Criteria: none
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be collected prior to, at mid-course and at the end of the course of IL-2 therapy.'}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-10-10

1 organization

2 products

1 drug

2 indications

Organization
University of Nebraska
Drug
interleukin-2
Indication
Renal Cell Carcinoma
Indication
Melanoma
Product
Gene expression analysis
Product
Mutation Analysis