Phase 2
Completed N=62
Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma
Source: ClinicalTrials.gov NCT00124657 ↗Enrolled (actual)
62
Serious AEs
55.2%
Results posted
Apr 2014
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicity (DLT) — 0; 0; 1; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicity (DLT) |
0; 0; 1; 2 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Erlotinib |
120 | — |
| PRIMARY Progression Free Survival (PFS) |
0.75; 0.33; 0.45; 0.19; NA; NA | — |
| SECONDARY Cmax of Erlotinib and Its Metabolite OSI-420 |
1.3; 1.6; 1.2; 1.8; 1.8; 1.3 | — |
| SECONDARY Erlotinib Tmax |
4; 3.1; 2.2; 2.2; 2.1; 2.6 | — |
| SECONDARY AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420 |
34.9; 23.9; 27.8; 37.1; 28.8; 21.2 | — |
| SECONDARY Number of Positive Mutations of EGFR and Downstream Pathways |
1; 1; 0 | — |
| SECONDARY Ability of Erlotinib to Inhibit EGFR Signaling |
— | — |
| SECONDARY Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment |
— | — |
| SECONDARY To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity |
— | — |
| SECONDARY Plasma and CSF Levels of VEGF, bFGF, and SDF1 |
— | — |
| SECONDARY Number of Participants Experiencing Grade 3 or 4 Toxicity Events |
2; 1; 7; 8; 2; 1 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00124657). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.