Status:
COMPLETED
Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Rady Children's Hospital, San Diego
Duke University
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
3-21 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when administered during and after radiotherapy in young patients with newly diagnosed high-grade g...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of high-grade glioma of 1 of the following types:
- Unfavorable low-grade glioma
- Gliomatosis cerebri or bithalamic involvement
- Histologically confirmed high-grade glioma (WHO grade III or IV) of 1 of the following subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Anaplastic ganglioglioma
- Pleomorphic xanthoastrocytoma with anaplastic features
- Malignant glioneuronal tumor
- Glioblastoma multiforme
- Gliosarcoma
- Newly diagnosed disease
- Intracranial or spinal cord tumors allowed
- PATIENT CHARACTERISTICS:
- Age
- 3 to 21
- Performance status
- Karnofsky 40-100% (age 17 to 21 years) OR
- Lansky 40-100% (age 3 to 16 years)
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3 (transfusion independent)
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
- Hepatic
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- SGPT \< 5 times ULN
- Albumin ≥ 2 g/dL
- Renal
- Creatinine \< 2 times normal OR
- Glomerular filtration rate \> 70 mL/min
- Cardiovascular
- No significant cardiovascular problem
- Pulmonary
- No significant pulmonary problem
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No uncontrolled infection
- No significant medical illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior or concurrent biologic agents
- Chemotherapy
- No prior or concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy
- Surgery
- No more than 42 days since prior surgery
- Other
- No other prior or concurrent anticancer or experimental treatment
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00124657
Start Date
March 1 2005
End Date
September 1 2014
Last Update
December 4 2015
Active Locations (3)
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1
University of California San Diego
San Diego, California, United States, 92123-4282
2
Duke Children's Hospital and Health Center
Durham, North Carolina, United States, 27710
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105