Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma

NCT00790452 | Terminated Phase 2 Results DMC

• 1 other identifier: 2007-0266
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Keywords

Brain; Hematologic Disorder; Venous Thromboembolism; Glioblastoma; Aspirin; Placebo; VTE; ASA; DVT

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Group 1 (Aspirin)

ACTIVE COMPARATOR

Aspirin 325 mg/day orally

Drug: Aspirin

Group 2 (Placebo)

PLACEBO COMPARATOR

Tablet/day orally

Drug: Placebo

Interventions

Aspirin DRUG

325 mg daily by mouth

Also known as: ASA

Group 1 (Aspirin)

Placebo DRUG

Tablet daily by mouth

Group 2 (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Glioblastoma; Hematologic Diseases; Venous Thromboembolism

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Hemic and Lymphatic Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Study terminated early due due to a drug supply issue.

Results Point of Contact

• Title: Victor A Levin, MD, BS / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Victor A Levin, MD,BS

  The University of Texas MD Anderson Cancer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 8, 2011
• Results First Posted: December 8, 2011

Record last verified: 2011-11

Locations

US (1)