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ACNS0822 A Randomized Phase II/III Study of Children with Newly Diagnosed High-Grade Gliomas

Purpose of study:

This study is being done in 3 parts. In Part 1 of this study we found the dose of vorinostat that can be given safely to subjects during radiation therapy. This dose will now be used in this part of the study, Part 2. Part 2 of this study will test and compare 3 treatments. Part 3 of this study will compare the 2 best treatments from Part 2. People who are in Part 2 of this study will not be in Part 3. We are now doing Part 2 of the study. You are being asked to enroll on Part 2 of this study.

The goals of Part 2 of this study are to:

  • Find out what effects, good and/or bad, chemoradiotherapy with vorinostat followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of vorinostat with radiation therapy is experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.
  • Find out what effects, good and/or bad, chemoradiotherapy with bevacizumab followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of bevacizumab with radiation therapy is experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.
  • Find out what effects, good and/or bad, chemoradiotherapy with temozolomide followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of temozolomide with radiation therapy is not experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.
  • Compare the effects of the three treatments above to find out which is better at getting rid of or shrinking tumors and has the least amount of side effects.

The goals of Part 3 of this study are to:

  • Compare the effects of two treatments to find out which is better at getting rid of or shrinking tumors and has the least amount of side effects. The two treatments are:
  • Chemoradiotherapy with [insert either bevacizumab or vorinostat] followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of [insert either bevacizumab or vorinostat] with radiation therapy is experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.
  • Chemoradiotherapy with temozolomide followed by maintenance therapy with bevacizumab and temozolomide has on people with newly diagnosed high-grade gliomas. The combination of temozolomide with radiation therapy is not experimental. Maintenance therapy with bevacizumab and temozolomide is experimental.

Who can participate:

Patients must be greater than or equal to 3 years and less than 22 years at the time of enrollment.

Patients must have a newly diagnosed high-grade glioma such as: anaplastic astrocytoma, glioblastoma multiforme,or gliosarcoma. Patients with primary spinal cord malignant gliomas are eligible. Patients with primary brainstem tumors are not eligible. Patients with a diagnosis of oligodendroglioma or oligoastrocytoma are NOT eligible.

Additional screening for eligibility will be required

What will happen during the study:

Random Assignment

Subjects (people participating in the study) will receive one of 3 different treatment plans. The treatment plan they receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer to make sure that there are about the same number of people on each treatment plan of the study.

Randomization: Subjects will be randomized to either Arm A with vorinostat, Arm B with temozolomide, or Arm C with bevacizumab. The radiation therapy itself will be the same in all groups of subjects. Maintenance therapy will also be the same in all groups of subjects.

Treatment Plan
The treatment plans involve cancer fighting medicine called chemotherapy and radiation therapy. The treatment on this clinical trial takes about 12 to 14 months. It is divided into 2 phases.
The first phase of treatment is called “chemoradiotherapy”. This phase lasts about 70 days, or 10 weeks. During this first phase, you will be given radiation therapy to the brain 5 days a week for 6 weeks. Within the first week of starting radiation therapy, you will begin taking one of 3 drugs (bevacizumab, vorinostat, or temozolomide) during this phase. You will continue taking the drug while you receive radiation therapy. After you complete radiation therapy and the treatment with the drug, you will have a 4-week rest, during which no treatment is given.

The second phase of treatment, called Maintenance therapy, begins after the 4-week rest period. During Maintenance therapy, you will not receive any further radiation therapy but you will have more chemotherapy. Maintenance therapy consists of 1 cycle of chemotherapy treatment repeated for up to a total of 12 cycles. Each cycle is 28 days long. During each cycle, you will receive two drugs, called bevacizumab and temozolomide. Temozolomide will be given
on 5 days and bevacizumab will be given on 2 days during each cycle. Maintenance therapy lasts about 336 days or 11 months.

The 3 treatment plans are the same except for a difference in what drug you will receive during chemoradiotherapy. All treatment plans will use the same radiation therapy. All treatment plans will use the same Maintenance chemotherapy.

Timing
The treatment plans involve cancer fighting medicine called chemotherapy and radiation therapy. The treatment on this clinical trial takes about 12 to 14 months. It is divided into 2 phases:
The first phase of treatment is called “chemoradiotherapy”. This phase lasts about 70 days, or 10 weeks.
The second phase is Maintenance therapy, and this phase lasts about 336 days or 11 months

Who to contact:

Dr. Laura Martin, Principal Investigator

laura.martin@nationwidechildrens.org
614/722-3583

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000