Erlotinib Alone or in Combination With Radiation Therapy in Treating Young Patients With Refractory or Relapsed Malignant Brain Tumors or Newly Diagnosed Brain Stem Glioma

NCT00360854 | Unknown Phase 1

• 7 other identifiers: CDR0000481539CCLG-NAG-2005-09ITCC-003EU-20617CCLG-CPP-05-07ROCHE-MO18461EUDRACT-2004-005247-10
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 21

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given alone or together with radiation therapy in treating young patients with refractory or relapsed malignant brain tumors or newly diagnosed brain stem glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem glioma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood ependymoma; recurrent childhood medulloblastoma; recurrent childhood supratentorial primitive neuroectodermal tumor; recurrent childhood visual pathway and hypothalamic glioma; childhood central nervous system germ cell tumor; childhood choroid plexus tumor; childhood craniopharyngioma; childhood grade I meningioma; childhood grade II meningioma; childhood grade III meningioma; childhood low-grade cerebral astrocytoma; childhood infratentorial ependymoma; childhood supratentorial ependymoma; recurrent childhood brain tumor; recurrent childhood subependymal giant cell astrocytoma; recurrent childhood pineoblastoma

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of erlotinib hydrochloride when given alone and in combination with radiotherapy

Secondary Outcomes (5)

• Dose-limiting toxicities

• Safety

• Pharmacokinetic behavior of erlotinib hydrocloride

• Efficacy

• Correlation of expression and mutations of epidermal growth factor receptor with treatment response

Interventions

erlotinib hydrochloride DRUG

mutation analysis GENETIC

polymorphism analysis GENETIC

laboratory biomarker analysis OTHER

pharmacological study OTHER

radiation therapy RADIATION

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Histologically or cytologically confirmed malignant brain tumor * Refractory to first-line therapy or relapsed after conventional therapy * No effective conventional therapy exists * Histologically confirmed brain stem glioma * Newly diagnosed disease * No pilocytic glioma * Measurable or evaluable disease PATIENT CHARACTERISTICS: * WHO performance status 0-2 OR Lansky play scale 50-100% * Patients with motor paresis due to disease are eligible * Neurological deficits must be stable for ≥ 1 week * Life expectancy ≥ 8 weeks * Absolute neutrophil count \> 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 8 g/dL * AST/ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Creatinine \< 1.5 times ULN OR creatinine clearance ≥ 70 mL/min * No other serious, uncontrolled illness * No active infection * No organ toxicity ≥ grade 2 except alopecia and neurological symptoms due to disease * Must be able to take oral medication * Patients with newly diagnosed brain stem glioma with difficulty swallowing may be eligible * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No evidence of pulmonary dysfunction or pre-existing lung disease * No myocardial infarction within the past year * No severe cardiac pathology * No significant ophthalmologic abnormality including, but not limited to, any of the following: * Severe dry eye syndrome * Keratoconjunctivitis sicca * Sjögren's syndrome * Severe exposure keratitis * Any other disorder likely to increase the risk of corneal epithelial lesions PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * More than 6 weeks since prior radiotherapy * No concurrent warfarin * No other concurrent anticancer or investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Cancer and Leukaemia Group: lead

Study Sites (21)

Our Lady's Hospital for Sick Children Crumlin

Dublin, 12, Ireland

Location

Birmingham Children's Hospital

Birmingham, England, B4 6NH, United Kingdom

Location

Institute of Child Health at University of Bristol

Bristol, England, BS2 8AE, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool Children's Hospital, Alder Hey

Liverpool, England, L12 2AP, United Kingdom

Location

Middlesex Hospital

London, England, W1T 3AA, United Kingdom

Location

Great Ormond Street Hospital for Children NHS Trust

London, England, WC1N 3JH, United Kingdom

Location

Central Manchester and Manchester Children's University Hospitals NHS Trust

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Queen's Medical Centre

Nottingham, England, NG7 2UH, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DU, United Kingdom

Location

Children's Hospital - Sheffield

Sheffield, England, S10 2TH, United Kingdom

Location

Southampton University Hospital NHS Trust

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Royal Belfast Hospital for Sick Children

Belfast, Northern Ireland, BT12 6BE, United Kingdom

Location

Royal Aberdeen Children's Hospital

Aberdeen, Scotland, AB25 2ZG, United Kingdom

Location

Royal Hospital for Sick Children

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, Scotland, G3 8SJ, United Kingdom

Location

Childrens Hospital for Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Familial ependymoma; Medulloblastoma; Optic Nerve Glioma; Choroid Plexus Neoplasms

Interventions

Erlotinib Hydrochloride; Amplified Fragment Length Polymorphism Analysis; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Therapeutics

Study Officials

• Darren Hargrave, MD

  Royal Marsden NHS Foundation Trust

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 7, 2006
• Study Start: May 1, 2005
• Last Updated: September 20, 2013

Record last verified: 2007-06

Locations

GB (20); IE (1)