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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00589290 |
RATIONALE: Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of thymoma and thymic carcinoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well belinostat works in treating patients with recurrent or metastatic thymoma and thymic carcinoma that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Thymoma and Thymic Carcinoma |
Drug: belinostat Procedure: DNA methylation analysis Procedure: flow cytometry Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Multicenter Phase II Study of Belinostat (PXD101) in Previously Chemotherapy Treated Thymoma and Thymic Carcinoma |
Estimated Enrollment: | 25 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for 12 courses and then every 4 weeks thereafter in the absence of disease progression or unacceptable toxicity.
Existing tumor blocks are analyzed for comparative genomic hybridization, methylation microarray analysis, and tissue immunohistochemistry studies. Blood samples are collected during courses 1 and 2 for circulating plasma biomarkers of response (including VEGF) and for protein hyperacetylation and T-cell modulation analyses by flow cytometry.
After completion of study treatment, patients are followed for 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive recurrent or metastatic thymoma or thymic carcinoma
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Inclusion Criteria:
Exclusion Criteria:
Uncontrolled medical illness including, but not limited to, any of the following:
History of another invasive malignancy in the past five years
PRIOR CONCURRENT THERAPY:
At least 28 days since any prior radiotherapy or major surgery
No concurrent use of any of the following medications:
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202-5289 | |
Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Giuseppe Giaccone, MD, PhD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000581356, NCI-08-C-0033, NCI-P07249 |
Study First Received: | December 25, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00589290 |
Health Authority: | Unspecified |
recurrent thymoma and thymic carcinoma invasive thymoma and thymic carcinoma |
Thoracic Neoplasms Thymoma Thymus Neoplasms |
Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Complex and Mixed |