UCSF BTC Clinical Trials

Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (VIGILANT)

 

Summary

This is an observational study of patients with central nervous system (CNS) tumors who have been prescribed Gliadel Wafer by their physicians as part of usual care.

Gliadel Wafers are made of a biodegradable polymer that is loaded with BCNU, a chemotherapy drug. Depending on the size of the tumor, gliadel wafer(s) are implanted directly to the tumor site following surgical removal of the tumor, for local controlled delivery of BCNU.

Long-term data will be collected on the safety and effectiveness of treatment with Gliadel Wafer from the time of a patient’s surgery, up to three years afterwards. For example, patients enrolled in this registry will complete various tests during their regular office visits, including a questionnaire about their well-being, as well as a cognitive test (called Karnofsky Performance Status).

 

Inclusion Criteria
  1. Signed informed consent, by the patient or a legally acceptable representative, obtained before any registry-related activities are undertaken. The informed consent must be signed within 14 calendar days after surgery.
  2. Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence.
  3. Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer and having signed consent to enroll in the registry within 14 calendar days after surgery for treatment of central nervous system (CNS) tumor(s), or are currently enrolled in another study where they received Gliadel Wafer. 
  4. Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient's medical records at Baseline and during participation in the registry.

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Exclusion Criteria
  1. The patient is enrolled in an interventional clinical trial, in which treatment for CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment.
  2. Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
  3. Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

Stay Informed