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Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00898547
First received: May 9, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.


Condition Intervention
Malignant Mesothelioma
 Other: immunoenzyme technique
Other: laboratory biomarker analysis

Study Type: Interventional
Official Title: Additional Circulating Markers of Angiogenesis and Disease in Mesothelioma Patients Treated on CALGB 30107

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma
U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Level of biomarkers, including thrombospondin I, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin (high vs low) [ Designated as safety issue: No ]
  • Effect of biomarker expression level on overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: November 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin portend a poor prognosis in patients with unresectable malignant mesothelioma treated with vatalanib on protocol CALGB-30107.
  • Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin correlate with response or stable disease in these patients.

OUTLINE: Serum samples previously obtained from patients on protocol CALGB-30107 are tested for levels of thrombospondin I serum, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin using enzyme-linked immunosorbent assays (ELISA).

PROJECTED ACCRUAL: A total of 47 specimens will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of malignant mesothelioma

    • Unresectable disease
  • Must have received treatment with vatalanib on protocol CALGB-30107

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898547

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: Robert A. Kratzke, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Monica M Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00898547     History of Changes
Other Study ID Numbers: CDR0000491313, U10CA031946, CALGB-150509
Study First Received: May 9, 2009
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on May 19, 2013