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Phase II Pilot Trial of Hyperbaric Hyperoxygenation in Conjunction With Radiotherapy and Temozolomide In Adults With Newly Diagnosed Glioblastomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastomas, Gliosarcoma

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Trial Information

Phase II Pilot Trial of Hyperbaric Hyperoxygenation in Conjunction With Radiotherapy and Temozolomide In Adults With Newly Diagnosed Glioblastomas


All enrolled study subjects will receive treatment. Nobody will receive placebo. Before
starting on-study, the investigators require standard blood tests (blood counts,
chemistries, liver function tests, etc), urinalysis, serum pregnancy test (females of
childbearing potential only) and an MRI with contrast (or CAT scan if you are unable to
obtain MRI) that the investigators routinely obtain before starting any new treatment or
chemotherapy.

Standard treatment for newly diagnosed glioblastomas after surgery begins with six weeks of
combined radiation (Monday-Friday) and chemotherapy with an oral drug called temozolomide
(Temodar) that patients normally take at home daily (including weekends) during the six
weeks. Patients then have four weeks off treatment. After four weeks off, patients resume
taking temozolomide on a monthly basis. During this phase of treatment, patients take a
higher dose of temozolomide for only five days out of every twenty eight days (they take the
drug only during the first five days of every 28 day cycle with the remaining 23 days off
drug). Patients continue taking temozolomide on a monthly basis until tumor progression,
they complete six to twelve months of treatment or they are unable to tolerate the drug any
longer due to side effects.

Temozolomide is typically taken once daily on an empty stomach one-half hour after taking an
anti-nausea medication that is also prescribed by your physician. Patients taking
temozolomide are also instructed to take lactulose as needed for constipation.

During the initial six weeks of combined radiation and chemotherapy, patients also take an
antibiotic to protect against a specific type of pneumonia that commonly occurs in people
with weakened immune systems (pneumocystis carinii). Following completion of the combined
phase of radiation and chemotherapy, continuation of the antibiotic depends upon the
discretion of the treating physician.

In this study, in addition to standard radiation and chemotherapy described above, the
patient 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 patient will need to have a chest x-ray performed to make certain
that you do not have any preexisting abnormal air spaces in the chest or lungs that could be
worsened by hyperbaric treatment. The hyperbaric treatment lasts approximately thirty
minutes. During the hyperbaric treatment, the patient will lie on a stretcher in the
hyperbaric chamber and breathe oxygen at greater than normal atmospheric pressure. The
investigators will monitor the increased oxygen levels in the tissue by placing a
noninvasive electrode on your skin. After each hyperbaric treatment, the investigators will
measure the participants blood sugar by finger-stick to check for hypoglycemia (low blood
sugar). If detected, hypoglycemia will be treated by standard medical measures.

Blood tests will be obtained as per routine standard of care (weekly during the initial six
weeks of combined radiation and chemotherapy) and on days # 21 and 28 (+/- 2 days) of each
cycle of monthly temozolomide.After the initial MRI (or CAT scan), subsequent MRI's (or CAT
scans) will be obtained per standard of care: four weeks after completion of radiation and
then generally after every two cycles of chemotherapy unless medically indicated at other
time points.

Other scans such as PET scans may be obtained if medically indicated as per standard of
care.

This study also looks to evaluate the effect of this treatment regimen on the quality of
life for the patient and level of stress. Therefore, the investigators will ask the patient
to complete three brief questionnaires at several different time points: before starting the
study, at the follow-up visit three to four weeks after completion of radiation, after
completion of every two cycles of monthly temozolomide and after coming off study (if
possible.) The patient will remain on study until completion of one year of treatment, the
patient may voluntarily elect to withdraw from study, the patient cannot tolerate further
treatment or side effects prevent continuing on study or there is evidence of tumor
progression.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

one year

Safety Issue:

Yes

Principal Investigator

J Paul Duic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

LIBTC-2008-2

NCT ID:

NCT00936052

Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Glioblastomas
  • Gliosarcoma
  • glioblastomas
  • GBM
  • gliosarcoma
  • blastoma
  • sarcoma
  • Glioblastoma
  • Gliosarcoma

Name

Location

Long Island Brain Tumor Center at Neurological surgery P.C.Commack, New York  11725