Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide
3 Years
21 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide
OBJECTIVES:
- Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high
grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of
complete and partial response rate in patients with postoperative measurable disease,
and in terms of the rate of freedom from recurrence in patients with no postoperative
measurable disease.
- Determine the 3 year overall and progression free survival rates in this patient
population when treated with adjuvant irinotecan followed by radiotherapy and
temozolomide.
- Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this
patient population.
OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on
weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan
and if appropriate, patients may undergo a second surgical resection.
Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second
resection, patients receive image guided external beam radiotherapy 5 days per week for 6
weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost
radiosurgery.
At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5
days. Treatment repeats every 3 weeks for 6 courses.
Patients are followed every 3 months for 2 years, then every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed brain tumors
- Grade III or IV disease:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic pleomorphic xanthoastrocytoma
- Anaplastic or malignant oligoastrocytoma
- Gemistocytic astrocytoma
- Malignant glioma
- Grade II glial tumors in unfavorable locations (i.e., imaging evidence of
gliomatosis cerebri and/or bithalamic involvement)
- Diffuse pontine gliomas with greater than 2/3 involvement of the pon
PATIENT CHARACTERISTICS:
Age:
- 3 to 21
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 2,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT less than 5 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior corticosteroids allowed
Radiotherapy:
- No prior radiotherapy
Surgery:
- No more than 28 days since prior definitive surgery for brain tumor
Other:
- Concurrent anticonvulsants allowed
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Amar Gajjar, MD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000067271
NCT ID:
NCT00004068
Start Date:
March 1999
Completion Date:
April 2003
Related Keywords:
- Brain and Central Nervous System Tumors
- childhood high-grade cerebral astrocytoma
- childhood high-grade cerebellar astrocytoma
- childhood oligodendroglioma
- untreated childhood brain stem glioma
- untreated childhood cerebellar astrocytoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
