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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003878 |
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.
Condition | Intervention | Phase |
---|---|---|
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: polifeprosan 20 with carmustine implant Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers |
Study Start Date: | April 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Supratentorial brain metastases for which surgery is recommended
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3295 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Emory University Hospital - Atlanta | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114-2617 | |
United States, Michigan | |
Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1030 | |
Lineberger Comprehensive Cancer Center, UNC | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pennsylvania Cancer Center | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-7811 |
Study Chair: | Alessandro Olivi, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000067044, NABTT-9802, JHOC-NABTT-9802 |
Study First Received: | November 1, 1999 |
Last Updated: | August 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00003878 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific tumors metastatic to brain |
Carmustine Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents |
Neoplasms Neoplastic Processes Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Carmustine Neoplasm Metastasis Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |