Radiation Therapy Followed By Combination Chemotherapy in Treating Young Patients With Supratentorial Primitive Neuroectodermal Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Children's Cancer and Leukaemia Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00274911
First received: January 10, 2006
Last updated: July 14, 2009
Last verified: June 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: cisplatin Drug: lomustine Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Non-Pineal Supratentorial Primitive Neuroectodermal Tumours |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Toxicity measured by hematological, gastrointestinal, mucosal, neurological, and skin morbidity during treatment and for 6 weeks after completion of treatment [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2004 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in pediatric patients with nonpineal supratentorial primitive neuroectodermal tumors.
Secondary
- Determine overall and relapse-free survival of patients treated with HART followed by adjuvant combination chemotherapy comprising lomustine, cisplatin, and vincristine.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Radiotherapy: Patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks.
- Adjuvant combination chemotherapy: Six weeks after the last radiotherapy dose, patients receive oral lomustine once and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 . Treatment repeats every 6 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274911
Locations
| Ireland | |
| Our Lady's Hospital for Sick Children Crumlin | |
| Dublin, Ireland, 12 | |
| United Kingdom | |
| Birmingham Children's Hospital | |
| Birmingham, England, United Kingdom, B4 6NH | |
| Institute of Child Health at University of Bristol | |
| Bristol, England, United Kingdom, BS2 8AE | |
| Addenbrooke's Hospital | |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Leicester Royal Infirmary | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Royal Liverpool Children's Hospital, Alder Hey | |
| Liverpool, England, United Kingdom, L12 2AP | |
| Great Ormond Street Hospital for Children | |
| London, England, United Kingdom, WC1N 3JH | |
| Royal London Hospital | |
| London, England, United Kingdom, E1 1BB | |
| Royal Manchester Children's Hospital | |
| Manchester, England, United Kingdom, M27 4HA | |
| Sir James Spence Institute of Child Health at Royal Victoria Infirmary | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
| Queen's Medical Centre | |
| Nottingham, England, United Kingdom, NG7 2UH | |
| Oxford Radcliffe Hospital | |
| Oxford, England, United Kingdom, 0X3 9DU | |
| Children's Hospital - Sheffield | |
| Sheffield, England, United Kingdom, S10 2TH | |
| Southampton General Hospital | |
| Southampton, England, United Kingdom, SO16 6YD | |
| Royal Marsden - Surrey | |
| Sutton, England, United Kingdom, SM2 5PT | |
| Royal Belfast Hospital for Sick Children | |
| Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
| Royal Aberdeen Children's Hospital | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
| Royal Hospital for Sick Children | |
| Edinburgh, Scotland, United Kingdom, EH9 1LF | |
| Royal Hospital for Sick Children | |
| Glasgow, Scotland, United Kingdom, G3 8SJ | |
| Childrens Hospital for Wales | |
| Cardiff, Wales, United Kingdom, CF14 4XW | |
Sponsors and Collaborators
Children's Cancer and Leukaemia Group
Investigators
| Study Chair: | Frank Saran, MD | Royal Marsden NHS Foundation Trust |
| Investigator: | Christopher Chandler, MD | King's College Hospital NHS Trust |
| Investigator: | Roger Taylor, MD | Cookridge Hospital |
| Investigator: | David Ellison, MD | Northern Centre for Cancer Treatment at Newcastle General Hospital |
| Investigator: | Barry Pizer, MD | Royal Liverpool Children's Hospital, Alder Hey |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00274911 History of Changes |
| Other Study ID Numbers: | CDR0000454540, CCLG-CNS-2004-01, EU-20580 |
| Study First Received: | January 10, 2006 |
| Last Updated: | July 14, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
untreated childhood supratentorial primitive neuroectodermal tumor |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Cisplatin Lomustine |
Vincristine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013