Completed

The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

polifeprosan 20 with carmustine implant

+ conventional surgery

DrugProcedure
Who is being recruted

Brain Diseases+9

+ Central Nervous System Diseases

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2002
See protocol details

Summary

Principal SponsorNew Approaches to Brain Tumor Therapy Consortium
Last updated: June 21, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2002

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant (Gliadel wafers). Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment. Determine the median, 6-month, 1-year, and 2-year survival of these patients on this regimen. Determine the incidence and severity of cognitive function loss of these patients on this regimen. Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen. OUTLINE: Patients receive up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) implanted in the resected tumor cavity. Patients are followed on day 7 or day of discharge, at 1 month, 3 months, every 3 months for 21 months, and then for survival. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

NCT00003878
Principal SponsorNew Approaches to Brain Tumor Therapy Consortium
Last updated: June 21, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNeoplasmsNeoplasms by SiteNeoplastic ProcessesNervous System DiseasesNervous System NeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsBrain NeoplasmsNeoplasm Metastasis

Criteria

DISEASE CHARACTERISTICS: Supratentorial brain metastases for which surgery is recommended Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR Two brain lesions consistent with metastases on MRI scan Lesions must be accessible through a single craniotomy Metastatic lesions clearly distinct from tumor bed of any benign lesions Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion No prior malignant intracranial neoplasm No lesion(s) in the brainstem No open communication of the resection cavity with the ventricle following resection PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic No concurrent hematologic disorders Hepatic No concurrent hepatic disease Renal No concurrent renal disease Cardiovascular No concurrent cardiac disease Pulmonary No concurrent pulmonary disorders Other Not pregnant or nursing Fertile patients must use effective contraception Mini mental score at least 15 No known hypersensitivity to carmustine or Gliadel wafers No other serious concurrent medical illness or infection PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No prior cranial irradiation Surgery See Disease Characteristics No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma) Other Concurrent systemic therapy allowed

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

H. Lee Moffitt Cancer Center and Research Institute

Tampa, United States

Emory University Hospital - Atlanta

Atlanta, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, United States
Completed11 Study Centers