Carmustine Implants in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003878
• Other study ID #: CDR0000067044
• Secondary ID: NABTT-9802JHOC-N
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 20, 2013
• Start date: April 2002
• Est. completion date: April 2003

Study information

• Verified date: July 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• polifeprosan 20 with carmustine implant

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
New Approaches to Brain Tumor Therapy Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,