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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00898547
Other study ID # CALGB-150509
Secondary ID U10CA031946CDR00
Status Terminated
Phase
First received
Last updated
Start date November 2005
Est. completion date August 2015

Study information

Verified date January 2019
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 47
Est. completion date August 2015
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
immunoenzyme technique

laboratory biomarker analysis


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Effect of biomarker expression level on overall survival Up to 10 years
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