Overview

Low-Dose Radiation and Combination Chemotherapy Following Surgery in Children With Newly Diagnosed Medulloblastoma

Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, but also damages normal cells in the developing brains of children. Combining low-dose radiation therapy in combination with chemotherapy should be effective in treating medulloblastoma while avoiding the long-term side effects of giving higher dose radiation to children with newly diagnosed average risk medulloblastoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborators:
Emory University
Stanford University
Treatments:
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Lomustine
Mesna
Vincristine
Criteria
Inclusion Criteria:

1. Histologically confirmed medulloblastoma

2. Standard-risk disease

3. No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI

- No tumor in the spinal or cerebral subarachnoid space by MRI

- No tumor in the subarachnoid space by Cerebrospinal fluid (CSF)

- No failure to perform staging studies (spine MRI and CSF cytology) preoperatively
or postoperatively

4. Must begin radiotherapy on study within 28 days after surgery

Exclusion Criteria:

1. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not
allowed.

2. Pregnant females will not be eligible

3. Patients must begin radiotherapy on protocol within 28 days of completion of surgery.
Exceptions need to be approved by the Principal Investigator.

4. Patients with the following will not be eligible:

- > 1.5cm3 residual tumor following resection as indicated by post-operative MRI.

- tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine

- tumor in subarachnoid space by CSF cytology

- failure to perform staging studies (spine MRI, CSF cytology) either pre- or post-
operatively