NCT00003878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Study Start

First participant enrolled

April 1, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

June 21, 2013

Status Verified

July 1, 2003

First QC Date

November 1, 1999

Last Update Submit

June 20, 2013

Conditions

Metastatic CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specifictumors metastatic to brain

Interventions

polifeprosan 20 with carmustine implantDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3295, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114-2617, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

MeSH Terms

Conditions

Neoplasm MetastasisBrain Neoplasms

Interventions

Carmustine

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • Alessandro Olivi, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 2002

Study Completion

April 1, 2003

Last Updated

June 21, 2013

Record last verified: 2003-07

Locations

US(11)