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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00898547
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 47
• Duration (Months): 117

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Malignant Mesothelioma	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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 47 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Additional Circulating Markers of Angiogenesis and Disease in Mesothelioma Patients Treated on CALGB 30107
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Level of biomarkers, including thrombospondin I, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin (high vs low) [baseline]

Secondary Outcome Measures

1. Effect of biomarker expression level on overall survival [Up to 10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00898547
• Other Study ID Numbers: CALGB-150509; U10CA031946; CDR0000491313
• First Posted: May 12, 2009
• Last Update Posted: Jan 24, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Alliance for Clinical Trials in Oncology: advanced malignant mesothelioma; recurrent malignant mesothelioma; epithelial mesothelioma; sarcomatous mesothelioma
• Additional relevant MeSH terms: Mesothelioma; Mesothelioma, Malignant; Lung Neoplasms

Study Results

No Results Posted as of Jan 24, 2019