Status:
COMPLETED
Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anaplastic Astrocytoma
Central Nervous System Neoplasm
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high en...
Detailed Description
PRIMARY OBJECTIVES: I. Compare event-free survival of pediatric patients with newly diagnosed high-grade gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide and lomus...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies:
- 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
- Performance status - Karnofsky 50-100% (for patients \> 16 years of age)
- Performance status - Lansky 50-100% (for patients ≤ 16 years of age)
- 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
- Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal
- 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 participation
- Able to swallow oral medication
- Seizures allowed provided they are well controlled with anticonvulsants
- No hypersensitivity to temozolomide
- No prior biologic agents
- No prior chemotherapy
- Prior corticosteroids allowed
- No concurrent corticosteroids as an antiemetic
- Concurrent corticosteroids allowed only for treatment of increased intracranial pressure
- 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
Exclusion
Key Trial Info
Start Date :
March 21 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00100802
Start Date
March 21 2005
End Date
June 30 2017
Last Update
February 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104