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Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, November 2008
First Received: November 7, 2008   Last Updated: November 11, 2008   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00790452
  Purpose

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.


Condition Intervention Phase
Glioblastoma
Drug: Aspirin
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title: A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To verify aspirin ability to lower the risk of VTE (blood clots in veins) in patients with GBM. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: November 2008
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 1: Active Comparator
Aspirin
Drug: Aspirin
325mg daily by mouth
Group 2: Active Comparator
Placebo
Drug: Placebo
Tablet daily by mouth

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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%

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790452

Contacts
Contact: Victor A Levin, MD,BS 713-792-2883

Locations
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Victor A Levin, MD,BS The University of Texas MD Anderson Cancer
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Victor Levin, MD/ BS/Professor )
Study ID Numbers: 2007-0266
Study First Received: November 7, 2008
Last Updated: November 11, 2008
ClinicalTrials.gov Identifier: NCT00790452     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Brain
Hematologic Disorder
Venous Thromboembolism
Glioblastoma
Aspirin
Placebo
VTE
ASA
DVT

Study placed in the following topic categories:
Anti-Inflammatory Agents
Glioblastoma
Fibrinolytic Agents
Thromboembolism
Fibrin Modulating Agents
Aspirin
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Anti-Inflammatory Agents, Non-Steroidal
Glioma
Analgesics
Astrocytoma
Hematologic Diseases
Cyclooxygenase Inhibitors
Vascular Diseases
Cardiovascular Agents
Venous Thromboembolism
Thrombosis
Neuroectodermal Tumors
Embolism and Thrombosis
Embolism
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Glioblastoma
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Fibrinolytic Agents
Thromboembolism
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Glioma
Analgesics
Neoplasms by Histologic Type
Astrocytoma
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Venous Thromboembolism
Thrombosis
Pharmacologic Actions
Neuroectodermal Tumors
Embolism and Thrombosis
Neoplasms
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on September 10, 2009