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.
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