Carmustine Implants in Treating Patients With Brain Metastases

• Sponsor: New Approaches to Brain Tumor Therapy Consortium (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003878
• Collaborator: National Cancer Institute (NCI) (NIH)
• Locations: 11
• Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Drug: polifeprosan 20 with carmustine implant; Procedure: conventional surgery	Phase 2

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.

Study Design

• Study Type: Interventional
• Primary Purpose: Treatment
• Official Title: The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
• Study Start Date: Apr 1, 2002
• Actual Study Completion Date: Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3295
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
3	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
4	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
5	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114-2617
6	Henry Ford Hospital	Detroit	Michigan	United States	48202
7	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
8	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1030
9	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
10	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
11	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811

Sponsors and Collaborators

• New Approaches to Brain Tumor Therapy Consortium
• National Cancer Institute (NCI)

Investigators

• Study Chair: Alessandro Olivi, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00003878
• Other Study ID Numbers: CDR0000067044; NABTT-9802; JHOC-NABTT-9802
• First Posted: Jan 27, 2003
• Last Update Posted: Jun 21, 2013
• Last Verified: Jul 1, 2003

• Keywords provided by , ,: unspecified adult solid tumor, protocol specific; tumors metastatic to brain
• Additional relevant MeSH terms: Brain Neoplasms; Carmustine

Study Results

No Results Posted as of Jun 21, 2013