Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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 to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients with newly diagnosed glioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborators: Duke University; Rady Children's Hospital, San Diego
• Treatments: Erlotinib Hydrochloride

Criteria

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