Clinical Study of Vorinostat in Combination With Etoposide in Pediatric Patients < 21 Years at Diagnosis With Refractory Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT01294670
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Relapsed/Refractory Sarcomas
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
4 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat and Etoposide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 9, 2011
Status verified
Dec 2020
Primary completion
Dec 8, 2020
Completion
Dec 8, 2020

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat and Etoposide
    This is a multi-center, open label, phase I/II trial of escalating doses of vorinostat in combination with etoposide.

Primary Outcome Measure

To Establish the Dose Limiting Toxicity (DLT) [ Time Frame: Patients will be assessed in 3-week cycles. ]

Locations (10)

FacilityCityStateZIPSite coordinators
Phoenix Children'S HospitalPhoenixArizona85016-
Children's Hospital ColoradoAuroraColorado80045-
Arnold Palmer Hospital for Children/MD Anderson Cancer Center OrlandoOrlandoFlorida32806-
All Children's HospitalSt. PetersburgFlorida33701-
John Hopkins Medical CenterBaltimoreMaryland21287-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Children's Mercy Hospital & ClinicsKansas CityMissouri64108-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Pennsylvania State University College of MedicineHersheyPennsylvania17110-
Md Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Phoenix, AZ

By research site
Phoenix Children'S Hospital· Phoenix, AZChildren's Hospital Colorado· Aurora, COArnold Palmer Hospital for Children/MD Anderson Cancer Center Orlando· Orlando, FLAll Children's Hospital· St. Petersburg, FLJohn Hopkins Medical Center· Baltimore, MDDana Farber Cancer Institute· Boston, MA

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