Biomarkers in Patients With High-Risk Melanoma Receiving High-Dose Interferon Therapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897520
First received: May 9, 2009
Last updated: December 23, 2009
Last verified: May 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer and predict how patients will respond to treatment.
PURPOSE: This research study is looking at biomarkers in patients with high-risk melanoma receiving high-dose interferon therapy.
| Condition | Intervention |
|---|---|
|
Melanoma (Skin) |
Biological: recombinant interferon alfa Genetic: proteomic profiling Other: immunoenzyme technique Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | PILOT-high Throughput-protein Profiling Analysis of Sera Collected From E1694 Patients Undergoing HDI (Arm B) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Serum sample screening via high throughput protein profiling in patients undergoing therapy [ Designated as safety issue: No ]
- Comparison of soluble factors [ Designated as safety issue: No ]
- Comparison of pre-therapy and post-therapy serum samples [ Designated as safety issue: No ]
- Kinetics of soluble factors' appearance, persistence, and disappearance during 12 months of therapy [ Designated as safety issue: No ]
- Predictive significance of specific soluble factors in pre-therapy samples [ Designated as safety issue: No ]
- Correlation of statistically significant factors with S100 and autoimmunity [ Designated as safety issue: No ]
- Confirmation of data obtained by Luminex technology [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To screen serum specimens using a high throughput protein profiling platform that tests for the highest number of known biomarkers (detectable by antibodies) that could be predictors of response to interferon treatment, autoimmunity, and disease outcome in patients with high-risk melanoma undergoing high-dose interferon (IFNa2b) therapy .
- To compare soluble factors across all patients at each time point (baseline and during therapy).
- To compare pre-therapy vs post-therapy serum samples from these patients.
- To assess the kinetics of soluble factors' appearance, persistence, and disappearance during the 12 months of therapy.
- To assess whether the amount of specific soluble factors in the pre-therapy sample is predictive of response independent of therapy.
- To correlate statistically significant factors with S100 and autoimmunity in these patients.
- To confirm the data obtained with the Luminex technology.
OUTLINE: Patients are stratified according to survival (< 2 years vs > 5 years).
Blood samples collected from patients enrolled in E-1694 are analyzed using high throughput protein profiling by ELISA to compare changes in levels of putative biomarkers of interferon alfa-2b, including cytokines and paired receptors, chemokines, cell adhesion molecules, metalloproteinases, angiogenic markers, growth factors, soluble receptors, signal transduction molecules, hormones, and other biomarkers of disease and dysregulated immune processes, at baseline and during therapy.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of high-risk melanoma
- Receiving interferon alfa-2b therapy in arm II of clinical trial E-1694
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00897520 History of Changes |
| Other Study ID Numbers: | CDR0000585297, ECOG-E1694T1 |
| Study First Received: | May 9, 2009 |
| Last Updated: | December 23, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage II melanoma stage III melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferons |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013