GlioblastomasPhase 2HBONCT00936052
Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma
A Phase 2 study testing Hyperbaric Oxygen Therapy in people with Glioblastomas and Gliosarcoma, run by Neurological Surgery, P.C. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastomas, Gliosarcoma
- What is being tested?
- Hyperbaric Oxygen Therapy
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Long Island Brain Tumor Center at Neurological surgery P.C.
Commack, New York, 11725
Julia Trojanowski, RN, 631-864-3900 ext. 18, neurooncologyli2@gmail.com
Kerry E McConie, RN, 516-478-0010 ext. 14, neurooncologyli@gmail.com
- Recruiting
Long Island Brain Tumor Center at Neurological Surgery P.C.
Great Neck, New York, 11021
Kerry E McConie, RN, 516-478-0010 ext. 14, neurooncologyli@gmail.com
Julia Trojanowski, RN, 631-864-3900 ext. 18, neurooncologyli2@gmail.com
About this study
Official title: Phase II Pilot Trial of Hyperbaric Hyperoxygenation in Conjunction With Radiotherapy and Temozolomide In Adults With Newly Diagnosed Glioblastomas
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.
Read the detailed description
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.
- Conditions
- Glioblastomas, Gliosarcoma
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- glioblastomas, GBM, gliosarcoma, blastoma, sarcoma
- Medical subject headings
- Glioblastoma, Gliosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
Also called 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurological Surgery, P.C.
- Sponsor type
- University, hospital or other
- Investigators
- J Paul Duic, MD, Principal investigator, Long Island Brain Tumor center at Neurological Surgery P.C.Jai Grewal, MD, Principal investigator, Long Island Brain Tumor Center at Neurological Surgery P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936052
- Sponsor's protocol ID
- LIBTC-2008-2
- Acronym
- HBO
- Status last verified
- Jul 2010
- First submitted
- 7 Jul 2009
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Trial of Hyperbaric Hyperoxygenation in Conjunction With Radiotherapy and Temozolomide In Adults With Newly Diagnosed Glioblastomas
- ClinicalTrials.gov ID
- NCT00936052
- Acronym / sponsor ID
- HBO / LIBTC-2008-2
- Conditions
- Glioblastomas, Gliosarcoma
- Keywords
- glioblastomas, GBM, gliosarcoma, blastoma, sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Neurological Surgery, P.C.University, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 9 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyAlso: Oxygenation, oxygen tankin 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 | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J Paul Duic, MD principal investigator
Long Island Brain Tumor center at Neurological Surgery P.C.
Jai Grewal, MD principal investigator
Long Island Brain Tumor Center at Neurological Surgery P.C.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric Oxygen Therapy in people with Glioblastomas and Gliosarcoma, run by Neurological Surgery, P.C. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerry E McConie, RN (516-478-0010 ext. 14, neurooncologyli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2010.