Innohep for Prophylaxis of Venous Thromboembolism in Brain Tumor Patients

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00629447
First received: February 27, 2008
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

To determine the safety of prophylaxis with Tinzaparin low molecular weight heparin in primary brain tumor patients. 2. To determine the incidence of deep venous thrombosis or pulmonary embolism in brain tumor patients who will be receiving Tinzaparin as primary prophylaxis. 3. To determine the overall survival of patients with malignant glioma who receive Tinzaparin. 4. To determine the bone density before and after prophylactic Tinzaparin.


Condition Intervention
Primary Brain Tumor
Drug: Innohep

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Trial of Innohep (Tinzaparin) Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumor Patients

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Neurologic evaluation, CBC, Coagulation test (PT w/ INR, aPTT),Karnofsky performance status, Thrombosis panel, Adverse events assessment [ Time Frame: MONTHS 2, 4, 6, 9, 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bone densitometry study (DEXA-Scan)d [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2004
Study Completion Date: October 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
Drug: Innohep
The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.
Other Name: Tinzaparin

Detailed Description:

Many patients with brain tumors develop thinning of the bones and weak bones, called osteoporosis. At baseline (or within 4 weeks of enrollment onto study) and 12 months the subject will have a bone densitometry study (DEXA-Scan) which is a test to determine bone density (the measure of the strength and thickness of bones) by using x-ray techniques.

A single arm pilot trial will be performed with newly diagnosed pathologically confirmed malignant glioma patients. The patients will receive low molecular weight heparin (Tinzaparin), which will begin at least 48 hours after craniotomy or stereotactic biopsy, but no later than four weeks after the most recent surgery.

The patients will receive a single daily subcutaneous injection of Tinzaparin at 4500 IU.

The primary analysis will be conducted at six months and the safety will be determined by the incidence of clinically significant bleeding, ≥ grade III/IV CNS hemorrhage or grade II hemorrhage elsewhere. The Tinzaparin will be discontinued for any grade II or higher hemorrhage, except CNS hemorrhage and patients with asymptomatic CNS hemorrhage seen on a scan (grade III) at study entry will stay on Tinzaparin, except if the CNS hemorrhage expands or there is a new hemorrhage, in which case the Tinzaparin will be discontinued. For patients without a CNS hemorrhage at entry, a new asymptomatic CNS hemorrhage (grade III), or a CNS hemorrhage with symptoms (≥ grade IV) will result in discontinuation of the Tinzaparin. If the patient does not have any hemorrhage, the Tinzaparin will be continued for an additional six months with the second analysis performed at 12 months. Patients may stay on Innohep as long as they are benefiting and there are no adverse reactions necessitation stopping therapy. Patients will continue to having the same labs and clinical follow-up.

  Eligibility

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

Inclusion Criteria:

  1. Patients with newly diagnosed pathologically confirmed WHO Grade III or Grade IV glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, gliosarcoma and glioblastoma multiforme);
  2. Patients must be 18 years of age or older at the time of informed consent;
  3. Karnofsky performance status 60% and a life expectancy of at least 6 months;
  4. The patient is at least 48 hours after craniotomy or stereotactic biopsy but no later than four weeks from the last surgical procedure;
  5. Adequate hematologic function as demonstrated by laboratory values performed within 14 days: platelet count > 100,000, prothrombin time (PT) 1.2 x control, inactivated partial thromboplastin time (aPTT) 1.2 x control;
  6. Signed informed consent prior to patient registration.

Exclusion Criteria:

  1. Presence of a coagulopathy, as defined by laboratory parameters including a platelet count < 100,000, PT > 1.2 x control or a PTT > 1.2 x control.
  2. Symptomatic intracranial bleeding, which includes inter- or intratumor bleeding and causes mass effect or neurological disability control;
  3. The presence of acute or chronic deep venous thrombosis demonstrated by ultrasonography or venography. A baseline screening ultrasound or venogram is not required;
  4. Active systemic bleeding, such as gastrointestinal bleeding or gross hematuria;
  5. Excessive risk of bleeding as defined by stroke within the prior 6 months, history of CNS or intraocular bleed, or septic endocarditis;
  6. Prior history of documented DVT or PE;
  7. History of immune mediated heparin induced thrombocytopenia, as documented by a platelet count < 50,000 and positive heparin-induced platelet aggregation test;
  8. Contraindication to tinzaparin or other heparins, including allergy or hypersensitivity to heparin or pork products, sulfite allergy, benzyl alcohol allergy or have or had had an epidural catheter or traumatic spinal puncture within 7 days prior to screening;
  9. Serum creatinine >3.0 mg/dl;
  10. Patient or partner of childbearing potential and not using adequate contraception;
  11. Pregnant or nursing (women of childbearing potential may have a screening pregnancy test at the discretion of the investigator);
  12. Medical condition requiring long-term anticoagulants such as atrial fibrillation or a mechanical heart valve;
  13. Inability to give informed consent;
  14. Inability to comply with study procedures, including subcutaneous injections and diagnostic procedures;
  15. Participating in another study of an investigational agent at the time of enrollment. The use of an experimental or investigational regimen of an approved product is not cause for exclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629447

Locations
United States, North Carolina
Duke University Health Systems
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Celgene Corporation
Investigators
Principal Investigator: James Vredenburgh, MD Duke University Heatlh Systems
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00629447     History of Changes
Other Study ID Numbers: Pro00008486, 4930
Study First Received: February 27, 2008
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
Primary Brain Tumor
Venous Thromboembolism
Heparin

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Embolism and Thrombosis
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Thrombosis
Vascular Diseases
Tinzaparin
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014