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Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Metastatic Medulloblastoma Who Have Undergone Surgery

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ClinicalTrials.gov Identifier: NCT00276666
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2006
Last Update Posted : September 17, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as lomustine, vincristine, and cisplatin, 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 together with combination chemotherapy after surgery may kill any tumor cells that remain.

PURPOSE: This phase II trial is studying giving radiation therapy together with combination chemotherapy to see how well it works in treating young patients with metastatic medulloblastoma who have undergone surgery.


Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: cisplatin Drug: lomustine Drug: vincristine sulfate Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in young patients with metastatic medulloblastoma.
  • Determine the toxicity of chemotherapy (vincristine during radiotherapy and 8 courses of lomustine, cisplatin, and vincristine after radiotherapy) in association with HART in these patients.

OUTLINE: This is a multicenter study.

  • Radiotherapy and vincristine: Beginning 4-6 weeks after surgery, patients undergo hyperfractionated accelerated radiotherapy (HART) twice a day, 5 days a week, for 5 weeks. Patients also receive vincristine IV once weekly for 8 weeks beginning in week 1*. Approximately 6-8 weeks after completion of radiotherapy, patients proceed to maintenance chemotherapy.

NOTE: *The first 7 patients undergo radiotherapy without receiving vincristine

  • Maintenance chemotherapy: Patients receive oral lomustine once on day 1 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 5 years.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma
Study Start Date : November 2001
Estimated Primary Completion Date : March 2010





Primary Outcome Measures :
  1. Toxicity


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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven medulloblastoma

    • The following variants of medulloblastoma are also eligible:

      • Nodular/desmoplastic medulloblastoma
      • Medullomyoblastoma
      • Melanotic medulloblastoma
  • Metastatic disease, meeting at least 1 of the following criteria:

    • Unequivocal evidence on pre- or post-operative MR scan of supratentorial (stage M2) metastases and/or spinal metastases (stage M3)
    • Tumor cells seen on cytospin analysis of lumbar cerebral spinal fluid (CSF) (stage M1) performed between 15 days and 21 days after surgery

      • Involvement of CSF pathways by tumor is defined as the unequivocal identification of primitive neuroectodermal cells, either on cytological grounds or with a combination of cytological and immunocytological features (e.g., reactivity for GFAP or a neuronal marker, such as synaptophysin)
  • Underwent surgery to remove the tumor no more than 6 weeks ago

PATIENT CHARACTERISTICS:

  • 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 (1-16 years) or Karnofsky (>16 years) performance status 30-100%
  • No active infection
  • No prior malignant disease
  • Not pregnant or nursing
  • No syndrome with recognized potential for increased sensitivity to radiotherapy and/or chromosomal fragility
  • Not require anesthesia
  • No hearing loss or renal impairment that would make the patient unable to comply with 'Packer' chemotherapy protocol

PRIOR CONCURRENT THERAPY:

  • No steroids, if possible, at the start of radiotherapy OR on a stable or reducing dose of steroids during the week before starting radiotherapy
  • No prior chemotherapy or radiotherapy
  • Dexamethasone should not be used as an anti-emetic unless other therapies fail

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276666


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
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
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
Royal London Hospital
London, England, United Kingdom, E1 1BB
Great Ormond Street Hospital for Children
London, England, United Kingdom, WC1N 3JH
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: Roger Taylor, MD Cookridge Hospital
OverallOfficial: Frank Saran, MD Royal Marsden NHS Foundation Trust
OverallOfficial: Barry Pizer, MD Royal Liverpool Children's Hospital, Alder Hey
OverallOfficial: David Ellison, MD Northern Centre for Cancer Treatment at Newcastle General Hospital
OverallOfficial: Susan V. Picton, MD Leeds Cancer Centre at St. James's University Hospital

ClinicalTrials.gov Identifier: NCT00276666     History of Changes
Other Study ID Numbers: CDR0000454549
CCLG-CNS-2001-06
EU-20577
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: June 2009

Keywords provided by National Cancer Institute (NCI):
untreated childhood medulloblastoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Medulloblastoma
Neoplasms by Site
Neoplasms
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cisplatin
Vincristine
Lomustine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents