Status:
COMPLETED
A Phase I/II Study of the Photon Radiosurgery System
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborating Sponsors:
Photoelectron Corporation
Conditions:
Brain Tumor, Recurrent
Glioblastoma Multiforme
Eligibility:
All Genders
2-32 years
Phase:
PHASE1
PHASE2
Brief Summary
The standard treatment for children with brain tumors is surgical removal of the tumor followed by radiation to the brain and chemotherapy (medicines) given to shrink any remaining tumor or to prevent...
Detailed Description
Central nervous system tumors account for approximately 20% of all childhood neoplasms. The treatment modalities used in the primary management of brain tumors are surgery, radiation therapy and chemo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- All patients must be between 2 and 32 yrs. of age. Patients who are pregnant or lactating will not be included in this study.
- Patients must have an estimated survival time of \> 3 months, and a Karnofsky performance status of \> 50% or and ECOG performance status of 0-2.
- Patient must have radiographic imaging evidence of tumor recurrence except for glioblastoma multiforme.
- The recurrent tumor prior to irradiation with PRS must be \< 4 cm.
- All patients must be \> 3 weeks from cytotoxic chemotherapy, except if patient received \< 1 week of non-myelotoxic chemotherapy. In that case, patient may be enrolled with permission of the principal investigator.
- All patients must be \> 6 weeks from high dose chemotherapy with stem cell rescue.
- All patients must be \> 3 weeks from prior radiation therapy.
- Patients with a history of prior irradiation will be included.
- Informed consent must be obtained prior to registration on the study.
- Tumor Sites:
- Brain
- Spinal Cord
- Tumor Types:
- Recurrent Medulloblastoma
- Recurrent Ependymoma (recurrence regardless of primary treatment)
- Recurrent Glioma
- Glioblastoma Multiforme
- Recurrent Craniopharyngioma
- Recurrent PNET (Primitive Neuroectodermal tumor)
- Recurrent Meningioma
- Recurrent Pineoblastoma
- Tumor Size:
- \< 4 cm in maximum diameter
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00179907
Start Date
May 1 2001
End Date
December 1 2013
Last Update
March 2 2015
Active Locations (1)
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1
Children's Memorial Hospital
Chicago, Illinois, United States, 60614