Eligibility

Ages Eligible for Study

18 years and up

Genders Eligible for Study

Both

Keywords

glioblastomas, GBM, gliosarcoma, blastoma, and sarcoma

Sponsors

Other

Neurological Surgery, P.C.

Inclusion Criteria

1. Greater than/equal to 18 years old;

2. histologically confirmed newly diagnosed WHO IV glioblastoma/gliosarcoma;

3. Subjects are eligible postoperatively following biopsy, subtotal or gross total
resection with or without radiographic evidence of residual disease;

4. recent contrast-enhanced MRI within 4 weeks of enrollment onto protocol;

5. no prior or concurrent antitumor therapy;

6. Karnofsky performance score >= 60;

7. no significant comorbidities;

8. signed informed consent;

9. adequate bone marrow function;

10. adequate liver and renal function;

11. males, females and minorities are eligible without any preference to gender or race;

12. negative serum pregnancy test.

Exclusion Criteria

1. Greater than/equal to 18 years old;

2. histologically confirmed newly diagnosed WHO IV glioblastoma/gliosarcoma;

3. Subjects are eligible postoperatively following biopsy, subtotal or gross total
resection with or without radiographic evidence of residual disease;

4. recent contrast-enhanced MRI within 4 weeks of enrollment onto protocol;

5. no prior or concurrent antitumor therapy;

6. Karnofsky performance score >= 60;

7. no significant comorbidities;

8. signed informed consent;

9. adequate bone marrow function;

10. adequate liver and renal function;

11. males, females and minorities are eligible without any preference to gender or race;

12. negative serum pregnancy test.

Detailed Description

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.