Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma (HBO)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Neurological Surgery, P.C..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Neurological Surgery, P.C.
Information provided by:
Neurological Surgery, P.C.
ClinicalTrials.gov Identifier:
NCT00936052
First received: July 7, 2009
Last updated: July 15, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastomas Gliosarcoma |
Other: Hyperbaric Oxygen Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Pilot Trial of Hyperbaric Hyperoxygenation in Conjunction With Radiotherapy and Temozolomide In Adults With Newly Diagnosed Glioblastomas |
Resource links provided by NLM:
Further study details as provided by Neurological Surgery, P.C.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Other: Hyperbaric Oxygen Therapy
- Oxygenation
- oxygen tank
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.
Other Names:
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936052
Contacts
| Contact: Kerry E McConie, RN | 516-478-0010 ext 14 | neurooncologyli@gmail.com |
| Contact: Julia Trojanowski, RN | 631-864-3900 | neurooncologyli2@gmail.com |
Locations
| United States, New York | |
| Long Island Brain Tumor Center at Neurological surgery P.C. | Recruiting |
| Commack, New York, United States, 11725 | |
| Contact: Julia Trojanowski, RN 631-864-3900 ext 18 neurooncologyli2@gmail.com | |
| Contact: Kerry E McConie, RN 516-478-0010 ext 14 neurooncologyli@gmail.com | |
| Principal Investigator: J Paul Duic, MD | |
| Principal Investigator: Jai Grewal, MD | |
| Long Island Brain Tumor Center at Neurological Surgery P.C. | Recruiting |
| Great Neck, New York, United States, 11021 | |
| Contact: Kerry E McConie, RN 516-478-0010 ext 14 neurooncologyli@gmail.com | |
| Contact: Julia Trojanowski, RN 631-864-3900 ext 18 neurooncologyli2@gmail.com | |
| Principal Investigator: J Paul Duic, MD | |
| Principal Investigator: Jai Grewal, MD | |
Sponsors and Collaborators
Neurological Surgery, P.C.
Investigators
| 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. |
More Information
Additional Information:
No publications provided
| Responsible Party: | J. Paul Duic, MD, Long Island Brain Tumor Center at Neurological Surgery, P.C. |
| ClinicalTrials.gov Identifier: | NCT00936052 History of Changes |
| Other Study ID Numbers: | LIBTC-2008-2 |
| Study First Received: | July 7, 2009 |
| Last Updated: | July 15, 2010 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Neurological Surgery, P.C.:
|
glioblastomas GBM gliosarcoma blastoma sarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013