Clinical trial NCT00003878: Carmustine Implants in Treating Patients With Brain Metastases
Official title: The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
tumors metastatic to brain
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Comprehensive Cancer Center
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Alessandro Olivi, MD
role: STUDY_CHAIR
References: