Metastatic CancerPhase 2NCT00003878
Carmustine Implants in Treating Patients With Brain Metastases
A Phase 2 study testing polifeprosan 20 with carmustine implant and conventional surgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by New Approaches to Brain Tumor Therapy Consortium at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- polifeprosan 20 with carmustine implant and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Apr 2002to Apr 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3295
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114-2617
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1030
About this study
Official title: The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
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.
Read the 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.
- Being tested
- polifeprosan 20 with carmustine implant, conventional surgery
- Keywords
- unspecified adult solid tumor, protocol specific, tumors metastatic to brain
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polifeprosan 20 with carmustine implantDrug
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2002
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- New Approaches to Brain Tumor Therapy Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Alessandro Olivi, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003878
- Sponsor's protocol ID
- CDR0000067044
- Other IDs
- NABTT-9802, JHOC-NABTT-9802
- Status last verified
- Jul 2003
- First submitted
- 1 Nov 1999
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
- ClinicalTrials.gov ID
- NCT00003878
- Acronym / sponsor ID
- CDR0000067044
- Keywords
- unspecified adult solid tumor, protocol specific, tumors metastatic to brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- New Approaches to Brain Tumor Therapy ConsortiumUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2002
- Study completion
- Apr 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polifeprosan 20 with carmustine implant | Drug | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Olivi, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing polifeprosan 20 with carmustine implant and conventional surgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by New Approaches to Brain Tumor Therapy Consortium at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013; AzTrials last refreshed its copy on 29 Oct 2026.