Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Karen D. Wright MD
Study ID
NCT01182350
Phase
PHASE2
Status
Terminated

Conditions

  • Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Diagnosis of diffuse intrinsic pontine glioma (DIPG) for decades has relied on imaging studies and clinical findings. Histologic confirmation has been absent with surgical biopsy of brainstem tumors not believed to have acceptable safety. The prognosis of DIPG has remained quite poor and novel therapeutic strategies are needed. This DIPG Biology and Treatment Study (DIPG-BATS) study incorporates a surgical biopsy at presentation using strict preoperative neurosurgical planning and stratifies participants to receive FDA-approved agents chosen on the basis of specific biologic targets. This is the first prospective national clinical trial to examine the feasibility and safety of incorporating surgical biopsy into potential treatment strategies for children with DIPG.

Key Dates

First listed
Aug 16, 2010
Start date
Sep 30, 2011
Status verified
Aug 2019
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
53 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: radiation + bevacizumab
    Cohort 1: MGMT-/EGFR- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles
  • Experimental: radiation + bevacizumab + erlotinib
    Cohort 2: MGMT-/EGFR+ Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles
  • Experimental: radiation + bevacizumab + temozolomide
    Cohort 3. MGMT+/EGFR- Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles
  • Experimental: radiation + bevacizumab + erlotinib + temozolomide
    Cohort 4. MGMT+/EGFR+ Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Radiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles

Primary Outcome Measure

9-month Overall Survival (OS) Rate [ Time Frame: 9 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Stanford University/Lucile Packard Children's HospitalPalo AltoCalifornia94304-
University of California, San FranciscoSan FranciscoCalifornia94143-
Children's Hospital ColoradoAuroraColorado80045-
Nemours Children's ClinicJacksonvilleFlorida32207-
Miami Children's HospitalMiamiFlorida33155-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Ann & Robert H Lurie Children's Hospital of ChicagoChicagoIllinois60611-
University of LouisvilleLouisvilleKentucky40202-
Johns HopkinsBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Children's Hospital of MichiganDetroitMichigan48201-
Children's Hospitals and Clinics of MinnesotaMinneapolisMinnesota55404-
Washington University Medical CenterSt LouisMissouri63110-
New York UniversityNew YorkNew York10016-
Duke UniversityDurhamNorth Carolina27710-
Doernbecher Children's HospitalPortlandOregon97239-
Penn State Hershey Medical CenterHersheyPennsylvania17033-
Medical University of South CarolinaCharlestonSouth Carolina29425-
UT Southwestern Medical CenterDallasTexas75390-
Cook Children's Medical CenterFort WorthTexas76104-
Seattle Children's HospitalSeattleWashington98105-

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