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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898547
First Posted: May 12, 2009
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Additional Circulating Markers of Angiogenesis and Disease in Mesothelioma Patients Treated on CALGB 30107

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

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) [ Time Frame: baseline ]

Secondary Outcome Measures:
  • Effect of biomarker expression level on overall survival [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
Samples retained from patients participating on CALGB-30107.

Estimated Enrollment: 47
Study Start Date: November 2005
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
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).
Other: immunoenzyme technique Other: laboratory biomarker analysis

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously enrolled on CALGB-30107 diagnosed with malignant mesothelioma.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898547


Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Robert A. Kratzke, MD Masonic Cancer Center, University of Minnesota
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898547     History of Changes
Other Study ID Numbers: CALGB-150509
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000491313 ( Registry Identifier: NCI Physician Data Query )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Alliance for Clinical Trials in Oncology:
advanced malignant mesothelioma
recurrent malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases