Clinical trial · Interventional
Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma
A Phase I/II Trial of a New Tyrosine Kinase Inhibitor (Tarceva; Erlotinib Hydrochloride; OSI-774) During and After Radiotherapy in the Treatment of Patients With Newly Diagnosed High Grade Glioma and Unfavorable Low-Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with High-Grade/Low-Grade Glioma
- description
- Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and \<26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.
- interventionNames
- Drug: Erlotinib hydrochloride
Primary outcomes (3)
- measure
- Number of Participants With Dose-limiting Toxicity (DLT)
- timeFrame
- During the first 8 weeks of therapy
- description
- DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase elevation that returned to grade 1 or baseline within 7 days. After enrollment of the first 4 participants, grade 3 and 4 electrolyte abnormalities that resolved to ≤grade 2 within 7 days were excluded as DLT. Toxicities were graded according to the Common Terminology Criteria for Adverse Events version 3.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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 treatmentReferences
Publications (0)
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