GlioblastomaPhase 2NCT00790452
Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma
A Phase 2 study testing Aspirin in people with Glioblastoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary objective: To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM). Secondary objectives: To determine clinical and laboratory factors which are associated with increased risk of VTE If it is determined that ASA reduces the incidence of VTE… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients with histologically proven supratentorial malignant WHO grade IV gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM) and gliosarcoma.
- The patient must have contrast enhancement documented on MRI or CT associated report.
- Understand and voluntarily sign an informed consent form.
- Karnofsky performance status of 60 or greater at study entry.
- Able to adhere to the study visit schedule and other protocol requirements.
- No more than 16 weeks from the diagnosis of glioblastoma, which is defined as the date of the surgical procedure establishing the histologic diagnosis operation.
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- No more than 1 recurrence of tumor following initial diagnosis.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: 1). At least 1 week has elapsed since the operation. 2). Any blood products visible on brain imaging (CT or MRI) are documented by the treating clinician or radiology report as residual and not active bleeding.
- Laboratory test results within these ranges: 1). The following two laboratory studies should be performed within14 days from enrollment if receiving cytotoxic chemotherapy; </= 90 days otherwise. (a) Platelet count greater than or equal to 50 x 10^9/L. (b). Hematocrit greater than or equal to 29.0.
- (10. continued) 2) For the following two laboratory studies, any documented prior normal value is acceptable (including outside institution results) provided that the patient is not taking anticoagulants such as coumadin. If not available, they should be checked. (a) Creatinine less than or equal to 1.5. (b) International Normalized Ratio less than or equal to 1.3. 3) D-Dimer blood test within the institutional normal level within 7-days of study entry
- Age 18 years or greater at the time of signing the informed consent form. Background data regarding VTE is from adults and may not be applicable to children.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Patients will be recruited with no preference to gender.
Who cannot join
- Patient is unable to provide informed consent.
- Pregnant or lactating females, as aspirin may impart addition risk for this patient population.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study as determined by the enrolling physician.
- Known hypersensitivity or allergy to aspirin.
- Clinical indication or use of agents with potential of increased bleeding risk via alteration of coagulation pathways or platelet activation including (but not limited to) warfarin, heparins, aspirin, dipyridamole, celecoxib, NSAIDs and clopidogrel. (1) Any use of warfarin, heparinoids, dipyridamole, clopidogrel for greater than 2 consecutive weeks in the prior 6 months (2) Occasional use of NSAIDs, aspirin, or COX-2 inhibitors is not an exclusion if taken on an "as needed" basis less than once per week on average.
- Diagnosed or suspected peptic ulceration within the last 5 years
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- History of gastrointestinal bleeding within the last 5 years.
- History of major bleeding (NCIC grade 3-4) within the last 5 years.
- Hereditary coagulopathy or hypercoagulable state.
- Anticipated refusal of blood products or maximal supportive care
- History of spontaneous (non-surgical) intracranial hemorrhage during lifetime.
- Active or recent uncontrolled gastrointestinal symptoms such as nausea, vomiting, and diarrhea, which are unresolved or within 2 weeks of resolution, or are anticipated to recur.
- Patient who would be unlikely or unwilling to follow-up at MD Anderson at or more frequently than every 3 months.
- No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows: American Indian or Alaskan Native - 0. Asian or Pacific Islander - <2%. Black, not of Hispanic Origin - 3%. Hispanic - 6%. White, not of Hispanic Origin - 88%. Other or Unknown - 2%. Total-100%.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma
Primary objective:
To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM).
Secondary objectives:
To determine clinical and laboratory factors which are associated with increased risk of VTE
If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to determine the clinical and laboratory factors which are associated with an increased benefit from the drug.
Read the detailed description
Study Drug:
Aspirin is designed to make blood less "sticky" and reduce its chances of clotting. By making blood less sticky, it may be less likely to allow a clot to form.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 study groups. If you are assigned to Group 1, you will take aspirin. If you are in Group 2, you will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know what group you are in. In case of an emergency, the study staff will be able to find out which group you are in.
Study Drug Administration:
If you are assigned to Group 1, you will take 1 aspirin tablet, once a day, by mouth. Aspirin should be taken with food and may be taken at any time during the day.
If you are assigned to Group 2, you will take 1 placebo tablet once a day, by mouth. The placebo should be taken with food and may be taken at any time during the day.
Study Visits:
While on study you will have tests and procedures performed at the same time as each routine clinical visit and when the study doctor thinks it may be necessary. The following tests and procedures will be performed:
- You will have a physical exam.
- You will be checked for VTE at each visit.
- Blood (2 teaspoons) will be drawn for routine tests at least once every 8 weeks. Blood samples will not be routinely collected if you are not receiving any chemotherapy.
- Blood (about 1 teaspoon) will be drawn to see how well your blood clots about 4 months after you begin treatment. If you show signs of VTE, this test will be done on the first visit after the signs are shown.
Length of Study:
You may remain on-study for as long as you are benefiting. If the disease gets worse or intolerable side effects occur, you may be taken off of the study.
End of Study Visit:
Once you are off-study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- You will have performance status evaluation.
- You will be asked about any medications you may be taking.
- You will be checked for VTE.
- Blood (about 1 teaspoon) will be drawn to see how well your blood clots.
- If you have symptoms of VTE, you will have a Doppler ultrasound test of your legs.
Follow-up:
The study staff will call you or a member of your family every 3 months, after your last clinic visit, to follow your health status.
This is an investigational study. Aspirin is approved by the FDA and commercially available. Its use in lowering the risk of VTE is investigational. Aspirin, and the study-related tests/procedures will be provided free of charge to you while on this study. Up to 224 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Glioblastoma
- Being tested
- Aspirin, Placebo
- Keywords
- Brain, Hematologic Disorder, Venous Thromboembolism, Glioblastoma, Aspirin, Placebo, VTE, ASA, DVT
- Medical subject headings
- Glioblastoma, Hematologic Diseases, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called ASA
325 mg daily by mouth
PlaceboDrug
Tablet daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Aspirin) | Active comparator | Aspirin 325 mg/day orally Receives: Drug: Aspirin |
| Group 2 (Placebo) | Placebo comparator | Tablet/day orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of VTE Events
Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.
Measured: VTE evaluation with study visits (4 weeks) for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor A Levin, MD,BS, Principal investigator, The University of Texas MD Anderson Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790452
- Sponsor's protocol ID
- 2007-0266
- Status last verified
- Nov 2011
- First submitted
- 7 Nov 2008
- Last updated
- 8 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma
- ClinicalTrials.gov ID
- NCT00790452
- Acronym / sponsor ID
- 2007-0266
- Conditions
- Glioblastoma
- Keywords
- Brain, Hematologic Disorder, Venous Thromboembolism, Glioblastoma, Aspirin, Placebo, VTE, ASA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 8 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
To determine whether aspirin (ASA) can lower the incidence of Venous Thromboembolism(VTE) in patients with Glioblastoma (GBM).
Secondary objectives:
To determine clinical and laboratory factors which are associated with increased risk of VTE
If it is determined that ASA reduces the incidence of VTE in patients with GBM, then to determine the clinical and laboratory factors which are associated with an increased benefit from the drug.
Detailed description
Study Drug:
Aspirin is designed to make blood less "sticky" and reduce its chances of clotting. By making blood less sticky, it may be less likely to allow a clot to form.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 study groups. If you are assigned to Group 1, you will take aspirin. If you are in Group 2, you will take a placebo. A placebo is a substance that looks like the study drug but has no active ingredients. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know what group you are in. In case of an emergency, the study staff will be able to find out which group you are in.
Study Drug Administration:
If you are assigned to Group 1, you will take 1 aspirin tablet, once a day, by mouth. Aspirin should be taken with food and may be taken at any time during the day.
If you are assigned to Group 2, you will take 1 placebo tablet once a day, by mouth. The placebo should be taken with food and may be taken at any time during the day.
Study Visits:
While on study you will have tests and procedures performed at the same time as each routine clinical visit and when the study doctor thinks it may be necessary. The following tests and procedures will be performed:
- You will have a physical exam.
- You will be checked for VTE at each visit.
- Blood (2 teaspoons) will be drawn for routine tests at least once every 8 weeks. Blood samples will not be routinely collected if you are not receiving any chemotherapy.
- Blood (about 1 teaspoon) will be drawn to see how well your blood clots about 4 months after you begin treatment. If you show signs of VTE, this test will be done on the first visit after the signs are shown.
Length of Study:
You may remain on-study for as long as you are benefiting. If the disease gets worse or intolerable side effects occur, you may be taken off of the study.
End of Study Visit:
Once you are off-study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam.
- You will have performance status evaluation.
- You will be asked about any medications you may be taking.
- You will be checked for VTE.
- Blood (about 1 teaspoon) will be drawn to see how well your blood clots.
- If you have symptoms of VTE, you will have a Doppler ultrasound test of your legs.
Follow-up:
The study staff will call you or a member of your family every 3 months, after your last clinic visit, to follow your health status.
This is an investigational study. Aspirin is approved by the FDA and commercially available. Its use in lowering the risk of VTE is investigational. Aspirin, and the study-related tests/procedures will be provided free of charge to you while on this study. Up to 224 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Aspirin) | Active comparator | Drug: AspirinAspirin 325 mg/day orally |
| Group 2 (Placebo) | Placebo comparator | Drug: PlaceboTablet/day orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with histologically proven supratentorial malignant WHO grade IV gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM) and gliosarcoma.
- The patient must have contrast enhancement documented on MRI or CT associated report.
- Understand and voluntarily sign an informed consent form.
- Karnofsky performance status of 60 or greater at study entry.
- Able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (14 listed)
- Patient is unable to provide informed consent.
- Pregnant or lactating females, as aspirin may impart addition risk for this patient population.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study as determined by the enrolling physician.
- Known hypersensitivity or allergy to aspirin.
- Clinical indication or use of agents with potential of increased bleeding risk via alteration of coagulation pathways or platelet activation including (but not limited to) warfarin, heparins, aspirin, dipyridamole, celecoxib, NSAIDs and clopidogrel. (1) Any use of warfarin, heparinoids, dipyridamole, clopidogrel for greater than 2 consecutive weeks in the prior 6 months (2) Occasional use of NSAIDs, aspirin, or COX-2 inhibitors is not an exclusion if taken on an "as needed" basis less than once per week on average.
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 |
|---|---|---|
| AspirinAlso: ASA325 mg daily by mouth | Drug | Group 1 (Aspirin) |
| PlaceboTablet daily by mouth | Drug | Group 2 (Placebo) |
Primary outcome
Frequency of VTE Events
Time frame: VTE evaluation with study visits (4 weeks) for up to 2 years
Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Victor A Levin, MD,BS principal investigator
The University of Texas MD Anderson Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin in people with Glioblastoma, run by M.D. Anderson Cancer Center at 1 site 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 14 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: stopped early, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of VTE Events (time frame: VTE evaluation with study visits (4 weeks) for up to 2 years). 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 8 Dec 2011.