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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Alessandro Olivi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067044

NCT ID:

NCT00003878

Start Date:

April 2002

Completion Date:

April 2003

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • tumors metastatic to brain
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Henry Ford HospitalDetroit, Michigan  48202
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195