Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma
Status unconfirmed · Phase 2
Conditions studied: Glioblastomas, Gliosarcoma
In brief
Standard treatment for glioblastomas includes radiation and chemotherapy with a drug called temozolomide (Temodar); however, glioblastomas frequently develop resistance to standard treatment and recur or progress. Glioblastomas are known to have decreased levels of oxygen compared to normal tissues. There is evidence that these lower oxygen levels in glioblastomas may contribute to their ability to resist treatment effects of radiation and chemotherapy. In this study we will look to increase the oxygen concentration within the glioblastoma by adding hyperbaric treatments (the experimental part of this study) to standard treatment with radiation and temozolomide in order to see whether increasing the oxygen concentration within the tumor increases the tumor-killing ability of standard radiation and chemotherapy. In addition, the investigators are interested to evaluate the effect of this treatment protocol on a person's quality of life and level of stress, and, therefore, the investigators will ask subjects to complete several brief questionnaires while they are on-study.
Key facts
- Study ID
- NCT00936052
- Run by
- Neurological Surgery, P.C.
- People needed
- 20
- Starts
- 2008-12-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2010-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Long Island Brain Tumor Center at Neurological surgery P.C. — Commack, New York, United States (enrolling)
- Long Island Brain Tumor Center at Neurological Surgery P.C. — Great Neck, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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