Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma
NCT01208454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2015-11-24
Summary
This phase I trial is studying the side effects and the best dose of vorinostat when given together with isotretinoin to see how well it works in treating patients with high-risk refractory or recurrent neuroblastoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may help vorinostat work better by making tumor cells more sensitive to the drug. Giving vorinostat together with isotretinoin may be an effective treatment for neuroblastoma.
Conditions
- Localized Unresectable Neuroblastoma
- Recurrent Neuroblastoma
- Regional Neuroblastoma
- Stage 4 Neuroblastoma
- Stage 4S Neuroblastoma
Interventions
- DRUG
-
Isotretinoin
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Pharmacological Study
Correlative studies
- DRUG
-
Vorinostat
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Julie Park · New Approaches to Neuroblastoma Treatment (NANT)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2014-09-30
Countries
- United States
- Canada
Study Locations
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