Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors

NCT00274911 | Unknown Phase 2

• 3 other identifiers: CCLG-CNS-2004-01CDR0000454540EU-20580
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 21

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, cisplatin, and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy followed by combination chemotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving radiation therapy followed by combination chemotherapy works in treating young patients with supratentorial primitive neuroectodermal tumors.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood supratentorial primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (1)

• Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment

Secondary Outcomes (1)

• Overall and relapse free survival at follow up every 2 months for 1 year, every 3 months for 2 years, and then every 6 months for 2 years

Interventions

cisplatin DRUG

lomustine DRUG

vincristine sulfate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically proven nonpineal supratentorial primitive neuroectodermal tumors * No supratentorial atypical teratoid/rhabdoid tumors or medulloepitheliomas * Localized or metastatic disease * Metastatic disease is defined as unequivocal evidence of supratentorial metastases and/or spinal metastases on pre-operative or postoperative MRI scan OR tumor cells seen on cytospin analysis of lumbar cerebrospinal fluid (stage M1) performed between 15 days and 21 days after surgery * Has undergone surgical resection within the past 4-6 weeks PATIENT CHARACTERISTICS: * Able to cooperate with twice daily fractions of radiotherapy * Hemoglobin ≥ 10 g/dL * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Neurologically stable (or improving) during the week before starting radiotherapy * Lansky performance status 30-100% (for patients 1 to 16 years of age) OR * Karnofsky performance status 30-100% (for patients over 16 years of age) * Must be able to comply with the chemotherapy protocol (e.g., no hearing loss, renal impairment) * No presence of active uncontrolled infection * No previous malignant disease * Not pregnant or nursing * No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility PRIOR CONCURRENT THERAPY: * No previous chemotherapy or radiotherapy * The patient should not be receiving steroids, if possible, at the start of radiotherapy or should be on a stable or reducing dose of steroids during the week before starting radiotherapy

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

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

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Great Ormond Street Hospital for Children

London, England, WC1N 3JH, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, England, M27 4HA, United Kingdom

Location

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

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 General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - 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

Interventions

Cisplatin; Lomustine; Vincristine; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Frank Saran, MD

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

• Christopher Chandler, MD

  King's College Hospital NHS Trust

• Roger Taylor, MD

  Cookridge Hospital

• David Ellison, MD

  Northern Centre for Cancer Treatment at Newcastle General Hospital

• Barry Pizer, MD

  Royal Liverpool Children's Hospital, Alder Hey

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: February 1, 2004
• Primary Completion: March 1, 2010
• Last Updated: August 2, 2013

Record last verified: 2009-06

Locations

IE (1); GB (20)