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A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma

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

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.


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.

Inclusion Criteria:

1. Patients with histologically proven supratentorial malignant WHO grade IV gliomas
will be eligible for this protocol. These include glioblastoma multiforme (GBM) and

2. The patient must have contrast enhancement documented on MRI or CT associated report.

3. Understand and voluntarily sign an informed consent form.

4. Karnofsky performance status of 60 or greater at study entry.

5. Able to adhere to the study visit schedule and other protocol requirements.

6. 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.

7. No more than 1 recurrence of tumor following initial diagnosis.

8. 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.

9. Laboratory test results within these ranges: 1). The following two laboratory studies
should be performed within14 days from enrollment if receiving cytotoxic
chemotherapy; 10^9/L. (b). Hematocrit greater than or equal to 29.0.

10. (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

11. 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.

12. 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.

Exclusion Criteria:

1. Patient is unable to provide informed consent.

2. Pregnant or lactating females, as aspirin may impart addition risk for this patient

3. 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

4. Known hypersensitivity or allergy to aspirin.

5. 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.

6. Diagnosed or suspected peptic ulceration within the last 5 years

7. History of gastrointestinal bleeding within the last 5 years.

8. History of major bleeding (NCIC grade 3-4) within the last 5 years.

9. Hereditary coagulopathy or hypercoagulable state.

10. Anticipated refusal of blood products or maximal supportive care

11. History of spontaneous (non-surgical) intracranial hemorrhage during lifetime.

12. 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

13. Patient who would be unlikely or unwilling to follow-up at MD Anderson at or more
frequently than every 3 months.

14. 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%.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Frequency of VTE Events

Outcome Description:

Occurrences of Venous Thromboembolism (VTE) events in each study arm of a randomized placebo controlled trial of aspirin in GBM Patients.

Outcome Time Frame:

VTE evaluation with study visits (4 weeks) for up to 2 years

Safety Issue:


Principal Investigator

Victor A Levin, MD,BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas MD Anderson Cancer


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

October 2009

Related Keywords:

  • Glioblastoma
  • Brain
  • Hematologic Disorder
  • Venous Thromboembolism
  • Glioblastoma
  • Aspirin
  • Placebo
  • VTE
  • ASA
  • DVT
  • Glioblastoma
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis



The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009