A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL

Part of paid clinical trials in Los Angeles, California.

Sponsor
Therapeutic Advances in Childhood Leukemia Consortium
Study ID
NCT01483690
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.
  • Vorinostat — DRUG
    180 mg/m2/day (Max dose=400mg daily) given orally on days 2 through 7 and days 16 through 21.
  • Vincristine — DRUG
    1.5 mg/m2/day (Max dose 2 mg) given IV push on days 10, 17, 24 and 31.
  • Dexamethasone — DRUG
    20 mg/m2/day divided BID given orally on days 8 through 12 and 22 through 26.
  • Mitoxantrone — DRUG
    10 mg/m2/day given on days 8 and 9 as a short IV infusion over 5-15 minutes; do not infuse over less than 3 minutes
  • Pegaspargase — DRUG
    2500 international units/m2/day IM or IV on days 10 and 24.
  • Methotrexate — DRUG
    Given intrathecally to all patients the dose defined by age below. * 8 mg for patients age 1-1.99 * 10 mg for patients age 2-2.99 * 12 mg for patients 3-8.99 years of age * 15 mg for patients \>9 years of age CNS 1 or 2 patients get doses on day 8, 22 and 35 and CNS 3 patients should get doses on day 8, 15, 22, 29 and 35

Study Details

This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).

Key Dates

Start date
Dec 31, 2011
Status verified
Oct 2020
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Initial Dose Level
    Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24
  • Experimental: Modified Dose Level
    Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21

Primary Outcome Measure

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT). [ Time Frame: 6 weeks ]

Locations (25)

FacilityCityStateZIPSite coordinators
Childrens Hospital Los AngelesLos AngelesCalifornia90027-
CHOCOrangeCalifornia--
UCSF School of MedicineSan FranciscoCalifornia94143-0106-
The Children's Hospital, University of ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia--
University of Miami Cancer CenterMiamiFlorida33136-
Children's Healthcare of Atlanta, Emory UniversityAtlantaGeorgia--
Lurie Children's HospitalChicagoIllinois--
Johns Hopkins UniversityBaltimoreMaryland--
Dana FarberBostonMassachusetts--
C.S. Mott Children's HospitalAnn ArborMichigan48109-0914-
Childrens Hospital & Clinics of MinnesotaMinneapolisMinnesota55404-4597-
University of Minnesota Children's HospitalMinneapolisMinnesota--
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Children's Hospital New York-PresbyterianNew YorkNew York10032-
New York University Medical CenterNew YorkNew York10016-
Levine Children's Hospital at Carolinas Medical CenterCharlotteNorth Carolina28203-
Nationwide Childrens HospitalColumbusOhio--
Oregon Health and Science UniversityPortlandOregon--
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. JudeMemphisTennessee38105-3678-
Vanderbilt Children's HospitalNashvilleTennessee--
University of Texas at SouthwesternDallasTexas--
Cook Children's Medical CenterFort WorthTexas76104-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Childrens Hospital Los Angeles· Los Angeles, CACHOC· Orange, CAUCSF School of Medicine· San Francisco, CAThe Children's Hospital, University of Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCUniversity of Miami Cancer Center· Miami, FL

Related Studies