A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
18 Years
N/A
Both
Metastatic Cancer
Trial Information
A Phase I/II Study Utilizing the Zeiss INTRABEAM System for the Treatment of a Resected Solitary Brain Metastasis
OBJECTIVES:
Primary
- Determine the 1-year local control rate in patients undergoing resection of a solitary
brain metastasis comprising intraoperative radiotherapy using the INTRABEAM® system.
Secondary
- Determine the survival of patients treated with this therapy.
- Determine distant recurrence of disease in patients treated with this therapy.
- Determine the toxicity of this therapy in these patients.
- Determine the quality of life of patients treated with this therapy.
OUTLINE: This is a nonrandomized study.
Patients undergo surgical resection of a brain metastasis. Patients then undergo
intraoperative radiotherapy using the INTRABEAM® system.
Quality of life is assessed at baseline and then every 3 months for 2 years.
Patients are followed within 48 hours after surgery, at 1 and 3 months, and then every 3
months for 2 years.
PROJECTED ACCRUAL: A total of 31-62 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan
- Resectable disease
- Histological evidence of metastatic carcinoma by intraoperative pathology
- No primary lymphoma, germ cell carcinoma, or small cell lung cancer
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 3 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No uncontrolled hypertension
- No unstable angina pectoris
- No uncontrolled dysrhythmias
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious infection
- No other medical illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior temozolomide or polifeprosan 20 with carmustine implant (Gliadel® wafer) for
brain metastasis
Endocrine therapy
- Not specified
Radiotherapy
- No prior brain radiotherapy of any kind, including local or whole brain external beam
radiotherapy, brachytherapy, or stereotactic radiosurgery
- No concurrent external beam radiotherapy to the brain
- Not planning adjuvant whole brain radiotherapy after study therapy
Surgery
- Not specified
Other
- No other prior conventional or investigational local or systemic agents for brain
metastasis
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local control rate as measured by MRI with contrast at 1 year
Safety Issue:
No
Principal Investigator
Robert Weil, MD
Investigator Role:
Study Chair
Investigator Affiliation:
The Cleveland Clinic
Authority:
Unspecified
Study ID:
CDR0000378144
NCT ID:
NCT00107367
Start Date:
April 2004
Completion Date:
Related Keywords:
- Metastatic Cancer
- tumors metastatic to brain
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
