Vorinostat Combined With Isotretinoin and Chemotherapy in Treating Younger Patients With Embryonal Tumors of the Central Nervous System

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00867178
Phase
PHASE1
Status
Completed

Conditions

  • Medulloblastoma
  • Pineoblastoma
  • Supratentorial Embryonal Tumor, Not Otherwise Specified

Eligibility Criteria

Sex
ALL
Age
2 Months - 47 Months
Healthy Volunteers
Not accepted

Interventions

  • 3-Dimensional Conformal Radiation Therapy — RADIATION
    Undergo conformal radiation therapy
  • Carboplatin — DRUG
    Given IV
  • Cisplatin — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Etoposide Phosphate — DRUG
    Given IV
  • Isotretinoin — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Peripheral Blood Stem Cell Transplantation — PROCEDURE
    Undergo PBSC
  • Thiotepa — DRUG
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV
  • Vorinostat — DRUG
    Given PO

Study Details

This pilot clinical trial studies the side effects and the best way to give vorinostat with isotretinoin and combination chemotherapy and to see how well they work in treating younger patients with embryonal tumors of the central nervous system. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as isotretinoin, vincristine sulfate, cisplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat with isotretinoin and combination chemotherapy may be an effective treatment for embryonal tumors of the central nervous system. A peripheral blood stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.

Key Dates

Start date
Feb 25, 2009
Status verified
Sep 2021
Primary completion
Apr 9, 2020
Completion
Dec 22, 2021

Study Design

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

Arms

  • Experimental: Treatment (vorinostat, isotretinoin, chemotherapy)
    See Detailed Description

Primary Outcome Measure

Dose-limiting toxicity of proposed vorinostat [ Time Frame: Up to 21 days ]

Locations (15)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
National Cancer Institute Pediatric Oncology BranchBethesdaMaryland20892-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Pediatric Brain Tumor ConsortiumMemphisTennessee38105-
Saint Jude Children's Research HospitalMemphisTennessee38105-
M D Anderson Cancer CenterHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Children's Hospital Los Angeles· Los Angeles, CALucile Packard Children's Hospital Stanford University· Palo Alto, CAChildren's National Medical Center· Washington D.C., DCLurie Children's Hospital-Chicago· Chicago, ILNational Cancer Institute Pediatric Oncology Branch· Bethesda, MDMemorial Sloan Kettering Cancer Center· New York, NY

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