Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma; Thromboembolism; Venous Thromboembolism
Intervention: Aspirin; Placebo
Intervention description: 325 mg daily by mouth; Tablet daily by mouth
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brain; Hematologic Disorder; Venous Thromboembolism; Glioblastoma; Aspirin; Placebo; VTE; ASA; DVT

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 in patients with GBM, then to
      determine the clinical and laboratory factors which are associated with an increased benefit
      from the drug.
    

Eligibility criteria:

        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
             gliosarcoma.

          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;
             </= 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. (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
             population.

          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 physician.

          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
             recur.

         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%.