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Status:

UNKNOWN

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

Lead Sponsor:

Children's Cancer and Leukaemia Group

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

3-21 years

Phase:

PHASE2

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 ...

Detailed Description

OBJECTIVES: * Determine the toxicity of hyperfractionated accelerated radiotherapy (HART) in young patients with metastatic medulloblastoma. * Determine the toxicity of chemotherapy (vincristine duri...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2001

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    29 Patients enrolled

    Trial Details

    Trial ID

    NCT00276666

    Start Date

    November 1 2001

    Last Update

    September 17 2013

    Active Locations (22)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (22 locations)

    1

    Our Lady's Hospital for Sick Children Crumlin

    Dublin, Ireland, 12

    2

    Birmingham Children's Hospital

    Birmingham, England, United Kingdom, B4 6NH

    3

    Institute of Child Health at University of Bristol

    Bristol, England, United Kingdom, BS2 8AE

    4

    Addenbrooke's Hospital

    Cambridge, England, United Kingdom, CB2 2QQ