Randomized Efficacy Study of TPI 287 to Treat Primary Refractory or Early Relapsed Neuroblastoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Giselle Sholler
Study ID
NCT01505608
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • TPI 287 — DRUG
    Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
  • Temozolomide — DRUG
    Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
  • Irinotecan — DRUG
    Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.

Study Details

The purpose of this research study is to evaluate a new investigational drug (TPI 287) for early relapsed neuroblastoma. An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the tumor's response to the study drug, TPI 287, in combination with Irinotecan and Temozolomide versus the combination of Irinotecan and Temozolomide alone. This study will also evaluate the safety and tolerability of the study drug, TPI 287.

Key Dates

Start date
Dec 31, 2011
Status verified
Aug 2024
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A- Temozolomide and Irinotecan
    1. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle. 2. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle. Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.
  • Experimental: Arm B- Temozolomide/Irinotecan + TPI 287
    Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287 1. Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle. 2. Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle. 3. Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.

Primary Outcome Measure

Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona--
Rady Children's HospitalSan DiegoCalifornia92123-
Connecticut Children's HospitalHartfordConnecticut06106-
Arnold Palmer Hospital for Children- MD AndersonOrlandoFlorida32806-
Helen DeVos Children's HospitalGrand RapidsMichigan49503-
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104-
Levine Children's HospitalCharlotteNorth Carolina28204-

Find similar trials in Phoenix, AZ

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Phoenix Children's Hospital· Phoenix, AZRady Children's Hospital· San Diego, CAConnecticut Children's Hospital· Hartford, CTArnold Palmer Hospital for Children- MD Anderson· Orlando, FLHelen DeVos Children's Hospital· Grand Rapids, MIChildren's Mercy Hospitals and Clinics· Kansas City, MO

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