Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma
HBO
Phase II Pilot Trial of Hyperbaric Hyperoxygenation in Conjunction With Radiotherapy and Temozolomide In Adults With Newly Diagnosed Glioblastomas
1 other identifier
interventional
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 16, 2010
July 1, 2010
2 years
July 7, 2009
July 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year
Secondary Outcomes (1)
to determine the health related quality of life of this treatment regimen and its influence upon subjects'' perceived level of traumatic stress throughout the course of treatment.
one year
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Long Island Brain Tumor Center at Neurological surgery P.C.
Commack, New York, 11725, United States
Long Island Brain Tumor Center at Neurological Surgery P.C.
Great Neck, New York, 11021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J Paul Duic, MD
Long Island Brain Tumor center at Neurological Surgery P.C.
- PRINCIPAL INVESTIGATOR
Jai Grewal, MD
Long Island Brain Tumor Center at Neurological Surgery P.C.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2009
First Posted
July 9, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 16, 2010
Record last verified: 2010-07