Study of MLN8237 in Combination With Irinotecan and Temozolomide

Part of paid clinical trials in Los Angeles, California.

Sponsor
New Approaches to Neuroblastoma Therapy Consortium
Study ID
NCT01601535
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • MLN8237 — DRUG
    Every course will be 21 days. MLN8237 will be administered orally daily starting on day 1 through day 7.
  • Irinotecan — DRUG
    Irinotecan will be administered intravenously during each course on study day 1 through day 5.
  • Temozolomide — DRUG
    Temozolomide will be administered orally during each course on study day 1 through day 5.

Study Details

The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide. The goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan, and temozolomide.

Key Dates

Start date
May 31, 2012
Status verified
Jul 2019
Primary completion
Jul 25, 2018
Completion
Jul 25, 2018

Study Design

Enrollment
54 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Every course will be 21 days. MLN8237 will be administered orally daily starting on day 1 through day 7. Irinotecan will be administered intravenously during each course on study day 1 through day 5. Temozolomide will be administered orally during each course on study day 1 through day 5.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma [ Time Frame: 21 days, from study day 1 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027-0700-
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo AltoCalifornia94304-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-
Children Hospital of ColoradoAuroraColorado80045-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
University of Chicago Comer Children's HospitalChicagoIllinois60637-
Childrens Hospital Boston, Dana-Farber Cancer Institute.BostonMassachusetts02115-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-3039-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-4318-
Cook Children's Medical Center - Fort WorthFort WorthTexas76104-
Children's Hospital and Regional Medical Center - SeattleSeattleWashington98105-

Find similar trials in Los Angeles, CA

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Hospital Los Angeles· Los Angeles, CALucile Packard Children's Hospital at Stanford University Medical Center· Palo Alto, CAUCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CAChildren Hospital of Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GAUniversity of Chicago Comer Children's Hospital· Chicago, IL

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