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

Stopped early · Phase 2

Conditions studied: Brain Tumors, Central Nervous System Tumors, Medulloblastoma

In brief

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.

Key facts

Study ID

NCT00031590

Run by

Children's Hospital of Philadelphia

People needed

30

Starts

2001-04-01

Expected to finish

2011-05-01

Last updated by the study team

2019-04-25

Who can join

Age: 3 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed medulloblastoma
• Standard-risk disease
• 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
• Must begin radiotherapy on study within 28 days after surgery

You may not qualify if…

• Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed.
• Pregnant females will not be eligible
• Patients must begin radiotherapy on protocol within 28 days of completion of surgery. Exceptions need to be approved by the Principal Investigator.
• 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

Where it is running

• Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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