131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat

Part of paid clinical trials in Los Angeles, California.

Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Study ID
NCT02035137
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.

Key Dates

Start date
Jul 31, 2014
Status verified
May 2022
Primary completion
Feb 26, 2021
Completion
Feb 26, 2021

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Single-Agent 131I-MIBG
    Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15.
  • Active Comparator: 131I-MIBG with Vincristine/Irinotecan
    Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
  • Active Comparator: 131I-MIBG with Vorinostat
    Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.

Primary Outcome Measure

Objective Tumor Response After One Course of Therapy [ Time Frame: 43-50 days from study day 1 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Childrens Hospital Los AngelesLos AngelesCalifornia90027-0700-
Lucile Salter Packer Children's HospitalPalo AltoCalifornia94304-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
Children Hospital of ColoradoAuroraColorado80045-
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlantaGeorgia30322-
University of Chicago, Comer Children's HospitalChicagoIllinois60637-
Children's Hospital BostonBostonMassachusetts02115-
C.S Mott Children's HospitalAnn ArborMichigan48109-
University of North CarolinaChapel HillNorth Carolina27599-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-4318-
Cook Children's Healthcare SystemFort WorthTexas76104-
Seattle Children's HospitalSeattleWashington98105-

Find similar trials in Los Angeles, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Childrens Hospital Los Angeles· Los Angeles, CALucile Salter Packer Children's Hospital· Palo Alto, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAChildren Hospital of Colorado· Aurora, COAFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus· Atlanta, GAUniversity of Chicago, Comer Children's Hospital· Chicago, IL

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