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
Sponsor:
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
  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
    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:
    • Oxygenation
    • oxygen tank
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014