Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma
3 Years
21 Years
Both
Brain and Central Nervous System Tumors
Trial Information
Hyperfractionated Accelerated Radiotherapy (HART) With Chemotherapy (Cisplatin, CCNU, Vincristine) for Metastatic (M1-3) Medulloblastoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Safety Issue:
Yes
Principal Investigator
Roger Taylor, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cookridge Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000454549
NCT ID:
NCT00276666
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
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