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A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma

Phase 2
3 Years
21 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma


- Compare event-free survival of pediatric patients with newly diagnosed high-grade
gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide
and lomustine with historical controls.

- Determine the toxicity of this regimen in these patients.

- Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with
this regimen.

- Correlate polymorphisms in GSTP1, GSTM1, and GSTT1 genes and GSTP1 protein expression
in tumors with survival in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

- Chemoradiotherapy: Patients receive oral temozolomide once daily on days 1-42. Patients
also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33,
and 36-40. Patients who did not undergo prior gross total resection also undergo boost
radiotherapy once daily on days 43-47.

- Maintenance chemotherapy: Four weeks after completion of chemoradiotherapy, patients
receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment
repeats every 42 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study within 1-1.5

Inclusion Criteria


- Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Gliosarcoma

- Primary spinal cord malignant gliomas allowed

- No primary brainstem tumors

- Has undergone surgical resection or biopsy of the tumor within the past 31 days

- Pre-operative and post-operative brain MRI with and without gadolinium-contrast
OR pre-operative and post-operative spine MRI for spinal cord primaries

- Post-operative MRI not required for patients who undergo biopsy only

- No evidence of neuraxis dissemination

- Spine MRI and cerebrospinal fluid cytology required only if clinically indicated



- 3 to 21

Performance status

- Karnofsky 50-100% (for patients > 16 years of age)

- Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

- At least 8 weeks


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3 (transfusion independent)

- Hemoglobin ≥ 8 g/dL (transfusions allowed)


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT ≤ 2.5 times ULN

- Albumin ≥ 2 g/dL


- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of


- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry ≥ 94% (if determination is clinically indicated)


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study

- Able to swallow oral medication

- Seizures allowed provided they are well controlled with anticonvulsants

- No hypersensitivity to temozolomide


Biologic therapy

- No prior biologic agents


- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

- No concurrent corticosteroids as an antiemetic

- Concurrent corticosteroids allowed only for treatment of increased intracranial


- No concurrent radiotherapy using cobalt-60


- See Disease Characteristics


- No other prior treatment

- No concurrent phenobarbital or cimetidine

- No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during
study chemoradiotherapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

Time to disease progression, disease relapse, occurence of a second malignant neoplasm, or death from any cause assessed at 1 year

Safety Issue:


Principal Investigator

Regina Jakacki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Pittsburgh of UPMC


United States: Federal Government

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood high-grade cerebral astrocytoma
  • childhood spinal cord neoplasm
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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