ACTRN12612000535875
Completed
Phase 1
In paediatric patients with high risk brain tumours, is it safe and feasible to infuse autologous Peripheral Blood Stem Cells transduced with a mutant MGMT Gene?
The Sydney Children's Hospital Network0 sites12 target enrollmentMay 21, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Childhood Brain Tumours
- Sponsor
- The Sydney Children's Hospital Network
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient diagnosed with one of the following:
- •a) High grade glioma which has progessed or recurred following standard therapy
- •b) Medulloblastoma which has recurred following conventional therapy
- •c) Ependymoma which has recurred following maximal safe surgical resection and radiotherapy, and where maximal safe re\-section and re\-irradiation has been undertaken or considered not appropriate
- •d) Atypical teratoid/rhabdoid tumour which has recurred
- •e) Low grade glioma which has recurred
- •f) Brainstem glioma of diffuse pontine type
- •2\. Life expectancy greater than or equal to 8 weeks
- •3\. No severe uncontrolled infection
- •4\. Performance status :
Exclusion Criteria
- •1\. Uncontrolled infection
- •2\. Malignant infiltration of the bone marrow or any other site outside the central nervous system
Outcomes
Primary Outcomes
Not specified
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