Status:
UNKNOWN
Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma
Lead Sponsor:
Neurological Surgery, P.C.
Conditions:
Glioblastomas
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Standard treatment for glioblastomas includes radiation and chemotherapy with a drug called temozolomide (Temodar); however, glioblastomas frequently develop resistance to standard treatment and recur...
Detailed Description
All enrolled study subjects will receive treatment. Nobody will receive placebo. Before starting on-study, the investigators require standard blood tests (blood counts, chemistries, liver function tes...
Eligibility Criteria
Inclusion
- Greater than/equal to 18 years old;
- histologically confirmed newly diagnosed WHO IV glioblastoma/gliosarcoma;
- Subjects are eligible postoperatively following biopsy, subtotal or gross total resection with or without radiographic evidence of residual disease;
- recent contrast-enhanced MRI within 4 weeks of enrollment onto protocol;
- no prior or concurrent antitumor therapy;
- Karnofsky performance score \>= 60;
- no significant comorbidities;
- signed informed consent;
- adequate bone marrow function;
- adequate liver and renal function;
- males, females and minorities are eligible without any preference to gender or race;
- negative serum pregnancy test.
Exclusion
- Greater than/equal to 18 years old;
- histologically confirmed newly diagnosed WHO IV glioblastoma/gliosarcoma;
- Subjects are eligible postoperatively following biopsy, subtotal or gross total resection with or without radiographic evidence of residual disease;
- recent contrast-enhanced MRI within 4 weeks of enrollment onto protocol;
- no prior or concurrent antitumor therapy;
- Karnofsky performance score \>= 60;
- no significant comorbidities;
- signed informed consent;
- adequate bone marrow function;
- adequate liver and renal function;
- males, females and minorities are eligible without any preference to gender or race;
- negative serum pregnancy test.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00936052
Start Date
December 1 2008
End Date
December 1 2010
Last Update
July 16 2010
Active Locations (2)
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1
Long Island Brain Tumor Center at Neurological surgery P.C.
Commack, New York, United States, 11725
2
Long Island Brain Tumor Center at Neurological Surgery P.C.
Great Neck, New York, United States, 11021