Recruiting
Phase 2

Hyperbaric Hyperoxygenation, Radiotherapy & Temozolomide

Sponsor:

Neurological Surgery, P.C.

Code:

NCT00936052

Conditions

Glioblastomas

Gliosarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen Therapy

Study Details

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 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.

Conditions

Glioblastomas

Gliosarcoma

Study ID

NCT00936052

Start date

Dec, 2008

Status verified date

Jul, 2010

Completion date

Dec, 2010

Anticipated

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Hyperbaric Oxygen Therapy

in addition to standard radiation and chemotherapy, you will also receive the experimental hyperbaric treatment prior to each radiation treatment (Monday-Friday) during the initial six weeks of treatment. Prior to the first hyperbaric treatment. The hyperbaric treatment lasts approximately thirty minutes. During the hyperbaric treatment, the participant will lie on a stretcher in the hyperbaric chamber and breathe oxygen at greater than normal atmospheric pressure. The investigator will monitor the increased oxygen levels in the tissue by placing a noninvasive electrode on your skin. After each hyperbaric treatment, we will measure your blood sugar by finger-stick to check for hypoglycemia (low blood sugar). If detected, hypoglycemia will be treated by standard medical measures.

Primary outcome measure

  • to generate preliminary data of the anti-tumor efficacy of hyperbaric oxygenation in conjunction with radiotherapy and chemotherapy,to determine median progression-free survival, to determine median survival and to determine median 2 year survival. [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Locations

Long Island Brain Tumor Center at Neurological surgery P.C.

Recruiting

Commack, New York, United States, 11725

Contacts

Principal Investigator:

J Paul Duic, MD

Long Island Brain Tumor Center at Neurological Surgery P.C.

Recruiting

Great Neck, New York, United States, 11021

Contacts

Principal Investigator:

J Paul Duic, MD

More Information

Sponsor

Neurological Surgery, P.C.

Last update posted

Jul 16, 2010

Last verified

Jul, 2010

Keywords

  • glioblastomas
  • GBM
  • gliosarcoma
  • blastoma
  • sarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurological Surgery, P.C. on 2010-07-16.