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Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma

Phase 2
3 Years
21 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

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Trial Information

Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma


- 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

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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Roger Taylor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cookridge Hospital


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms