Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Baylor College of Medicine
Study ID
NCT00879437
Phase
PHASE2
Status
Completed

Conditions

  • Anaplastic Astrocytoma
  • Brainstem Glioma
  • Diffuse Intrinsic Pontine Glioma
  • Glial Cell Tumors
  • Glioblastoma Multiforme
  • Gliomatosis Cerebri
  • Gliosarcoma
  • Malignant Gliomas

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Valproic acid — DRUG
    Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT. Dosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml
  • Bevacizumab — DRUG
    All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.
  • Radiation therapy — RADIATION
    Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks.

Study Details

Currently, there are few effective treatments for the following aggressive brain tumors: glioblastoma multiforme, anaplastic astrocytoma, gliomatosis cerebri, gliosarcoma, or brainstem glioma. Surgery and radiation can generally slow down these aggressive brain tumors, but in the majority of patients, these tumors will start growing again in 6-12 months. Adding chemotherapy drugs to surgery and radiation does not clearly improve the cure rate of children with malignant gliomas. The investigators are conducting this study to see if the combination of valproic acid and bevacizumab (also known as AvastinTM) with surgery and radiation will shrink these brain tumors more effectively and improve the chance of cure.

Key Dates

First listed
Apr 10, 2009
Start date
Sep 1, 2009
Status verified
Jun 2021
Primary completion
Aug 30, 2015
Completion
Oct 2, 2017

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: valproic acid and radiation, followed by valproic acid and bevacizumab
    radiation phase (week 1-6): daily valproic acid and radiation, for approximately 6 weeks post-radiation phase (week 7-10): valproic acid daily maintenance phase (starting week 11): daily valproic acid, and bevacizumab once every 2 weeks; to continue for a maximum duration of 2 years

Primary Outcome Measure

1-year Event Free Survival (EFS) [ Time Frame: 12 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73126-
Children's Medical Center Dallas, Center for Cancer and Blood DisordersDallasTexas75235-
Cook Children's Medical CenterFort WorthTexas76104-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-
University of Texas Health Science CenterSan AntonioTexas78207-

Find similar trials in Oklahoma City, OK

By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OKChildren's Medical Center Dallas, Center for Cancer and Blood Disorders· Dallas, TXCook Children's Medical Center· Fort Worth, TXMD Anderson Cancer Center· Houston, TXTexas Children's Hospital· Houston, TXUniversity of Texas Health Science Center· San Antonio, TX

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