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

Phase I Component: Histologic confirmation of relapsed/refractory solid tumors, including tumors of the central nervous system that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Patients with diffuse pontine glioma are not required to have histologic confirmation of disease, and are eligible with radiologic confirmation. Phase II Component: the population will be restricted to relapsed/refractory sarcomas

Patient must be between 4-21 years of age at the time of study enrollment. Efforts will be made to enroll patients \<13 years of age so that adequate information about the biologic effects of this agent in younger patients can be obtained.

Patient must have Karnofsky \> or = to 60% for patients \>10 years of age; Lansky Play Scale \> or = to to 60 for children \< or = to 10 years of age

Patient must have a life expectancy of \> 8 weeks.

There is no limit to the number of prior treatment regimens provided that performance status and life expectancy meet the criteria above.

Absolute neutrophil count (ANC) ≥ 1000 / mcL

Platelets ≥100,000 / mcL (transfusion not permitted)

Hemoglobin ≥ 9 g/dL qualifications (transfusion permitted)

Coagulation Prothrombin Time or INR ≤ 1.5x upper limit of normal (ULN)

Serum creatinine ≤ 1.5x upper limit of normal (ULN) OR calculated creatinine clearance ≥ 60 mL/min for patients with creatinine levels \> 1.5x institutional ULN. or calculated creatinine clearance Creatinine clearance should be calculated per institutional standard.

Serum total bilirubin ≤ 1.5 x ULN Patient's who don't meet this criteria must have a Direct bilirubin ≤ 1.5 x ULN

AST (SGOT) and ALT (SGPT) Alkaline Phosphatase (liver fraction)

≤ 2.5 x ULN. If AST or ALT is \> 2.5 x ULN, then the liver fraction of Alkaline Phosphatase should be ≤ 2.5 x ULN

Phase I component: Patients may have measurable or non-measurable disease. Phase II component: Patients may only have measurable disease.

Patient must have no persistent toxicities from prior therapy \> or = to Grade 2 with the exception of hematologic indices (i.e. hemoglobin, WBC, ANC, ALC).

For females of childbearing potential, a negative serum pregnancy test must be documented within 72 hours of receiving the first dose of vorinostat.

Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent.

Female patients of childbearing potential must be willing to use 2 adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study, starting with visit 1.

Male patients must agree to use an adequate method of contraception for the duration of the study.

Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

Myelosuppressive chemotherapy: At least 2 weeks must have elapsed since the administration of previous therapy. Six weeks must have elapsed since administration of nitrosoureas or mitomycin C. Seven days must have elapsed since the administration of G-CSF and/or GM-CSF.

Biologic agents: At least 14 days must have elapsed since the completion of therapy with a biologic agent such as a monoclonal antibody. Seven days must have elapsed since the last dose of retinoids.

Radiation therapy (XRT): \> or = to 2 weeks must have elapsed for local XRT (small port); \> or = to 6 months must have elapsed if prior radiation to \> or = to 50% of the pelvis or if other substantial bone marrow irradiation, including total body irradiation.

Patient must be able to swallow capsules.

Patient must have an available archival/pre-treatment block or fresh tumor biopsy for molecular profiling to be performed.

What this study is about