Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Conditions

• Anaplastic Astrocytoma
• Anaplastic Oligoastrocytoma
• Diffuse Intrinsic Pontine Glioma
• Gliosarcoma

Eligibility Criteria

Sex

ALL

Age

37 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• 3-Dimensional Conformal Radiation Therapy — RADIATION
  Undergo 3D conformal radiation therapy
• Intensity-Modulated Radiation Therapy — RADIATION
  Undergo intensity-modulated radiation therapy
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Vorinostat — DRUG
  Given PO

Study Details

This phase I/II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with radiation therapy followed by maintenance therapy with vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a brainstem tumor). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with radiation therapy may kill more tumor cells.

Key Dates

Start date

Aug 9, 2010

Status verified

Oct 2021

Primary completion

Jun 30, 2017

Completion

Sep 30, 2021

Study Design

Enrollment

79 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1 Phase I Vorinostat 180 mg/m^2
  Patients in phase I received vorinostat at 180 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm 2 Phase 1 Vorinostat 230 mg/m^2
  Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2
  Patients received a higher dose of vorinostat at 230 mg/m\^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m\^2/ day PO on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Vorinostat [ Time Frame: Planned 7 weeks during chemoradiotherapy ]

Locations (174)

Find similar trials in Birmingham, AL

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