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A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Brain Cancer

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Trial Information

A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer


Inclusion Criteria:



1. Can provide signed/dated Informed Consent, and Health Insurance Portability and
Accountability Act of 1996 (HIPAA) authorization.

2. Are a male or female patient 18 years of age or older.

3. Are willing to a use barrier method of contraception if fertile or of childbearing
potential until 30 days after surgical resection. If the patient receives subsequent
chemotherapy during study participation (as allowed by the protocol), appropriate
contraception will be managed by the principal investigator.

4. Have a primary diagnosis of solid-based tumor cancer (except small cell lung cancer
(SCLS), lymphoma, germ cell cancer or anaplastic thyroid cancer) or unknown primary
cancer and have 1-3 brain metastasis(es) for which surgical resection is planned for
a single metastasis and any remaining metastases are planned for stereotactic
radiosurgery (SRS);

OR

an intra-operative diagnosis of metastatic brain tumor in a patient with a single
brain lesion.

5. Have a life expectancy of ≥12 weeks.

6. Have a Karnofsky Performance Status (KPS) score of 70 or higher.

7. Have Recursive Partitioning Analysis (RPA) status of 1 or 2.

8. Women of childbearing potential must have a negative serum or urine pregnancy test
within 14 days of the surgical resection; and

9. Patients must be able to understand English, either orally or in writing, and be able
to consent and complete the required assessments and procedures.

Exclusion Criteria:

1. Are unable or unwilling to understand study assessment or to cooperate with the study
procedures as determined by the investigator.

2. Have a history of allergic reaction or known hypersensitivity to BCNU (carmustine) or
other components of the GLIADEL, such as polifeprosan polymer.

3. Have a history of prior cranial irradiation.

4. Have a prior diagnosis of Central Nervous System (CNS) tumor.

5. Have received prior treatment for brain tumors.

6. Have had prior exposure to GLIADEL or its components, such as polifeprosan polymer.

7. Have any uncontrolled medical or psychiatric conditions which preclude them from
participating in or completing the study procedures.

8. Concurrent severe medical conditions include, but are not limited to, active
infection, acute hepatitis, cardiac arrhythmia, unstable angina, congestive heart
failure, uncontrolled diabetes mellitus, uncontrolled seizures, pulmonary
insufficiency, pulmonary fibrosis, pulmonary embolus, etc.

9. Have a diagnosis of tumor in the brain stem or posterior fossa.

10. Have an RPA status of 3.

11. Have a diagnosis of leptomeningeal disease at time of enrollment; or

12. Are currently pregnant or lactating, or plan to become pregnant during the course of
the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Eight neurocognitive assessments will be used to assess the primary objective of evaluating the preservation of neurocognitive function over time.

Outcome Time Frame:

One year or until the patient has evidence of neurological deterioration due to CNS metastasis, has a local recurrence, withdraws, dies, is lost to follow-up, or the study is closed.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GLIA-001

NCT ID:

NCT00525590

Start Date:

September 2007

Completion Date:

March 2011

Related Keywords:

  • Metastatic Brain Cancer
  • Gliadel
  • Brain Neoplasms

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Temple UniversityPhiladelphia, Pennsylvania  19140
University of North CarolinaChapel Hill, North Carolina  27599
Cleveland ClinicCleveland, Ohio  44195
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of California, Los AngelesLos Angeles, California  
The University of ChicagoChicago, Illinois  60637
The Ohio State University Medical CenterColumbus, Ohio  43210
UT Southwestern Medical Center at DallasDallas, Texas  75390
University of South FloridaTampa, Florida  33612
Methodist University HospitalMemphis, Tennessee  38104
University of Arizona / University Medical CenterTucson, Arizona  85724
NorthShore University HealthSystem Reseach InstituteEvanston, Illinois  60201
Weill Medical College Department of Neurological SurgeryNew York City, New York  10021
Carolina Neurosurgery & Spine AssociatesCharlotte, North Carolina  28204
Trinity Mother Frances Health SystemTyler, Texas  75702