Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma

NCT00360945 | Unknown Phase 2

• 3 other identifiers: CDR0000482280CCLG-CNS-2004-02EU-20622
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 23

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood oligodendroglioma; untreated childhood cerebellar astrocytoma; childhood high-grade cerebral astrocytoma; childhood low-grade cerebral astrocytoma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; recurrent childhood brain tumor

Outcome Measures

Primary Outcomes (1)

• Response rate after 2 courses

Secondary Outcomes (4)

• Relapse-free survival

• Best response in patients receiving more than 2 courses

• Rate of progression at 6 months and 1 and 2 years

• Overall survival

Interventions

cisplatin DRUG

temozolomide DRUG

fluorescence in situ hybridization GENETIC

loss of heterozygosity analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

radiation therapy RADIATION

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors\*: * Glioblastoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic oligoastrocytoma * Anaplastic ganglioglioma * Anaplastic mixed tumor * Glial component is essential NOTE: \*Malignant gliomas occurring as a second primary malignancy allowed * Newly diagnosed or recurrent disease * No malignant brain stem tumors * Incompletely resected tumors * No completely resected tumors * Measurable or evaluable disease by conventional MRI PATIENT CHARACTERISTICS: * Lansky performance status 40-100% * Organ toxicity ≤ grade 2 * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Prothrombin ≥ 50% * Fibrinogen ≥ 1.5 g/L * Creatinine normal for age * Creatinine ≤ 65 µmol/L (4-15 years of age) * Creatinine ≤ 110 µmol/L (15-20 years of age) * Audiogram with toxicity grade ≤ 2 * ECG normal * Negative pregnancy test * Fertile patients must use effective contraception * No severe or life-threatening infection * No uncontrolled developing or symptomatic intracranial hypertension PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy for patients with relapsed disease * No prior cisplatin or temozolomide * No other concurrent anticancer therapy

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 (23)

Institut Gustave Roussy

Villejuif, F-94805, France

Location

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

Bristol Royal Hospital for Children

Bristol, England, BS2 8BJ, 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; Oligodendroglioma; Astrocytoma

Interventions

Cisplatin; Temozolomide; In Situ Hybridization, Fluorescence; Immunohistochemistry; 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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Histocytochemistry; Immunologic Techniques; Therapeutics

Study Officials

• Steve Lowis, MD, PhD, BA, MRCP, MRCPCH

  Bristol Royal Hospital for Children

• Jacques Grill, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

• Anthony Michalski, MD

  Great Ormond Street Hospital for Children NHS Foundation Trust

• David A. Walker

  Queen's Medical Center

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 1, 2004
• Last Updated: September 17, 2013

Record last verified: 2006-11

Locations

IE (1); GB (21); FR (1)