Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01294670|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : December 9, 2020
The purpose of this study is to find out how safe and effective treatment with a new combination of drugs, vorinostat and etoposide, is in treating cancer. The medication etoposide is a standard medication used in the treatment of cancer in children. Vorinostat is an experimental drug which targets a protein(s) that control the way cancer cells grow and divide. Vorinostat is approved by the FDA in adults with certain cancers but not approved yet in children.
There are two parts to this study. In the first part of this study, the phase I portion, a safe dose of the combination, vorinostat and etoposide. The goal of second part of this study, the phase II portion, is to see how effective the combination of vorinostat and etoposide is in treating cancer.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors Relapsed/Refractory Sarcomas||Drug: Vorinostat and Etoposide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors|
|Actual Study Start Date :||February 9, 2011|
|Actual Primary Completion Date :||December 8, 2020|
|Actual Study Completion Date :||December 8, 2020|
Experimental: Vorinostat and Etoposide
This is a multi-center, open label, phase I/II trial of escalating doses of vorinostat in combination with etoposide.
Drug: Vorinostat and Etoposide
Patients will be assessed in 3-week cycles. Escalating doses of vorinostat will be administered orally on a daily x 4 schedule in combination with a fixed dose of etoposide. Etoposide will be administered intravenously daily x 3 days. Cohorts of 3-6 patients will be treated with vorinostat and etoposide. In the phase II component, patients will be treated at the RP2D established in the Phase I component of the study, which was found to be 270 mg/m2/dose of Vorinostat and 100 mg/m2/dose of Etoposide.
- To establish the Dose Limiting Toxicity (DLT) [ Time Frame: Patients will be assessed in 3-week cycles. ]of the novel combination vorinostat and etoposide in pediatric patients with refractory solid tumors including tumors of the central nervous system. The Toxicity will be evaluated according to NCI CTCAE Version 4.0.
- To establish the Maximum Tolerated Dose (MTD) [ Time Frame: 1 year ]of the novel combination vorinostat and etoposide in pediatric patients with refractory solid tumors including tumors of the central nervous system.
- To establish the efficacy (CR (Complete Response) + PR (Partial Response) rate) [ Time Frame: 1 year ]of the novel combination vorinostat and etoposide in pediatric patients with relapsed/refractory sarcoma. Evaluation for response will be determined by Revised RECIST guideline
- To evaluate the efficacy (CR (complete response) + PR (partial response) rate) [ Time Frame: 1 year ]of the novel combination vorinostat and etoposide in pediatric patients enrolled in the phase I component of the study. Evaluation for response will be determined by Revised RECIST guideline.
- To evaluate the biologic effects using Histone Acetylation, Gene Expression Profiling, and Histone Phosphorylation Profiling. [ Time Frame: 2 years ]of the novel combination of vorinostat and etoposide in pediatric patients with refractory solid tumors including central nervous system tumors
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): NCT01294670
|United States, Arizona|
|Phoenix Children'S Hospital|
|Phoenix, Arizona, United States, 85016|
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Arnold Palmer Hospital for Children/MD Anderson Cancer Center Orlando|
|Orlando, Florida, United States, 32806|
|All Children's Hospital|
|Saint Petersburg, Florida, United States, 33701|
|United States, Maryland|
|John Hopkins Medical Center|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Children's Mercy Hospital & Clinics|
|Kansas City, Missouri, United States, 64108|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Pennsylvania State University College of Medicine|
|Hershey, Pennsylvania, United States, 17110|
|United States, Texas|
|Md Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Alberta Children'S Hospital|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Tanya Trippett, MD||Memorial Sloan Kettering Cancer Center|