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:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00898547
First received: May 9, 2009
Last updated: July 31, 2015
Last verified: July 2015
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of biomarker expression level on overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898547

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

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00898547     History of Changes
Other Study ID Numbers: CALGB-150509, U10CA031946, CDR0000491313
Study First Received: May 9, 2009
Last Updated: July 31, 2015
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 02, 2015