A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT00890786
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Newly Diagnosed High-Grade Gliomas

Eligibility Criteria

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

Interventions

  • Temozolomide — DRUG
    High Grade Glioma Temozolomide during radiotherapy: 90mg/m2/day PO daily (for patients ≤ 18 years of age); 75mg/m2/day PO daily (for patients ≥ 19 years of age); must begin by Day 5 of radiotherapy for a total of 42 days consecutively. High Grade Glioma Temozolomide during maintenance chemotherapy: 150mg/m2/day PO on Days 1-5.
  • Bevacizumab — DRUG
    High Grade Glioma Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Day 22 (± 2 days)and Day 36 (± 2 days) of radiotherapy. High Grade Glioma Bevacizumab during maintenance chemotherapy:10 mg/kg as a 90 minute infusion on Day 1 (+ 2 days)and Day 15 (± 2 days) of each course. Diffuse Intrinsic Pontine Gliomas Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Days 1 (+ 2 days),15, 29, and 43(±2 days for all 3 doses) of radiotherapy. Diffuse Intrinsic Pontine Gliomas Bevacizumab during maintenance chemotherapy: 10 mg/kg as a 90 minute infusion on Day 1 (+2 days)and 15 (±2 days).
  • Irinotecan — DRUG
    High Grade Glioma Irinotecan during maintenance chemotherapy:125 mg/m2/day IV over 90 minutes on Days 1 (+ 2 days)and 15 (±2 days) of each course, given no sooner than one hour after temozolomide on Day 1. Diffuse Intrinsic Pontine Gliomas Irinotecan maintenance chemotherapy: 125 mg/m2/day IV on Day 1 (+2 days)and Day 15 (±2 days).

Study Details

The outcome for children with high-grade gliomas and diffuse intrinsic brainstem gliomas remains poor despite the use of multi-modal therapy with surgery, radiation therapy and chemotherapy.

Key Dates

Start date
May 31, 2009
Status verified
May 2018
Primary completion
Oct 31, 2014
Completion
Dec 31, 2017

Study Design

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

Arms

  • Experimental: HGG
    Temozolomide, Bevacizumab, and Irinotecan according to the treatment schedule in the intervention section.
  • Experimental: DIPG
    Temozolomide, Bevacizumab, and Irinotecan according to the treatment schedule in the interventions section.

Primary Outcome Measure

To determine the toxicities and feasibility of the proposed treatment regimen in patients with high-grade glioma and diffuse intrinsic brainstem glioma [ Time Frame: 2-3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60614-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

Find similar trials in Chicago, IL

By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILCincinnati Children's Hospital Medical Center· Cincinnati, OH

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