Status:
TERMINATED
Radiosurgery for Glioblastoma Multiforme
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
66+ years
Phase:
PHASE1
PHASE2
Brief Summary
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients...
Detailed Description
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients...
Eligibility Criteria
Inclusion
- Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy.
- Patient must recover from the effects of surgery, post-operative infection, or other complications.
- Therapy should start within 5 weeks of surgery
- Must have an estimated survival of \> 8 weeks.
- KPS \< 70.
- Age \> 65 years.
- Must have a pre- and post operative contrast enhanced MRI scans
- Laboratory values within the following limits: ANC (absolute neutrophil count) \>/= 1500 cell/ul Platelets \>/= 100x 10(3)/ul, Hemoglobin \>/= 9g/dl, Serum Creatinine ≤ 1.5mg/dl., Serum total Bilirubin \</= 1.5 x upper limit of normal (ULN), SGOT/SGPT \</= 2.5x ULN, Albumin \>/= 3g/dl.
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Exclusion
- Histology grade less than Anaplastic Glioma ( WHO Grade III).
- Recurrent malignant glioma.
- Tumor involving the Brain stem.
- Any detected tumor foci beyond the cranial vault.
- Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy.
- Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for \> 5 years.
- Prior chemotherapy for the current disease.
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Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00456612
Start Date
February 1 2007
End Date
December 1 2010
Last Update
March 6 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215