Vorinostat and Isotretinoin in Treating Patients With High-Risk Refractory or Recurrent Neuroblastoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01208454
Phase
PHASE1
Status
Completed

Conditions

  • Localized Unresectable Neuroblastoma
  • Recurrent Neuroblastoma
  • Regional Neuroblastoma
  • Stage 4 Neuroblastoma
  • Stage 4S Neuroblastoma

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Isotretinoin — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Dec 31, 2010
Status verified
Nov 2015
Primary completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Treatment (isotretinoin and vorinostat)
    Patients receive isotretinoin PO BID on days 1-14, PO suspension\* of vorinostat QD on days 1-4 of course 1, and capsules of vorinostat PO QD on days 1-4 and 8-11 of course 2 and subsequent courses. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. EXPANSION COHORT 1 (=\< 21 years of age): Once the MTD has been determined, patients are treated at that dose level as above. EXPANSION COHORT 2 (22-30 years of age): Patients receive isotretinoin as above and vorinostat at the MTD on days 1-3 and 8-10.

Primary Outcome Measure

Incidence of toxicity as assessed by NCI CTCAE v. 4.0 [ Time Frame: Up to 3 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
UCSF Medical Center-ParnassusSan FranciscoCalifornia94143-
Children's Hospital ColoradoAuroraColorado80045-
Children's Healthcare of Atlanta - EglestonAtlantaGeorgia30322-
University of Chicago Comer Children's HospitalChicagoIllinois60637-
Boston Children's HospitalBostonMassachusetts02115-
C S Mott Children's HospitalAnn ArborMichigan48109-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Cook Children's Medical CenterFort WorthTexas76104-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By research site
Children's Hospital Los Angeles· Los Angeles, CALucile Packard Children's Hospital Stanford University· Palo Alto, CAUCSF Medical Center-Parnassus· San Francisco, CAChildren's Hospital Colorado· Aurora, COChildren's Healthcare of Atlanta - Egleston· Atlanta, GAUniversity of Chicago Comer Children's Hospital· Chicago, IL

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