Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.

Official Title

Treatment of Children With Diffuse Intrinsic Brain Stem Glioma With Standard Dose Irradiation and Vincristine Plus Oral VP-16, A POG Pilot Study

Conditions

Brain and Central Nervous System Tumors

Study Type

Interventional

Study Design

Treatment

Further Details

Objectives:

1. Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma.
2. Assess the toxicity of this regimen in this patient population.

• Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy.
• Maintenance: One week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Start

September 1999

Eligibility & Criteria

• Ages Eligible for Study: 3 Years – 21 Years
• Genders Eligible for Study: Both

Disease Characterisics:

• Newly diagnosed diffuse intrinsic brain stem glioma by MRI At least 2/3 of the tumor in the pons Tumor origin clearly in the pons At least 2 clinical features with less than 6 months duration: Cranial nerve deficit Long tract signs Ataxia No diffuse brain stem enlargement secondary to neurofibromatosis No diffuse leptomeningeal disease

Patient Characterisics:

• Age: 3 to 21
• Performance status: Karnofsky or Lansky 50-100%
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count at least 1,000/mm3, Platelet count at least 100,000/mm3
• Hepatic: Bilirubin less than 2.0 mg/dL ALT no greater than 5 times upper limit of normal
• Renal: Creatinine or GFR normal for age

Prior Concurrent Therapy:

• Biologic therapy: No prior biologic therapy
• Chemotherapy: No other concurrent chemotherapy; No prior chemotherapy
• Endocrine therapy: Prior glucocorticoids allowed Radiotherapy: No prior radiotherapy
• Surgery: No prior surgery
• Other: No other concurrent investigational drugs

Total Enrolment

30

Contact Details

• Royal Children’s Hospital, Parkville, Victoria, 3052, Australia
• More information here
• Results reported here