RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Stereotactic radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. Giving internal radiation therapy after surgery with or without radiosurgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well internal radiation therapy with or without stereotactic radiosurgery works in treating patients who have undergone surgery for newly diagnosed brain metastases.

Condition	Treatment or Intervention	Phase
brain metastases	Procedure: brachytherapy  Procedure: conventional surgery  Procedure: radiation therapy  Procedure: stereotactic radiosurgery  Procedure: surgery	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the 6-month and 1-year local control rate in patients with newly diagnosed supratentorial brain metastases treated with brachytherapy using the intracavity GliaSite^® Radiation Therapy System (RTS) after surgical resection.

Secondary

• Determine the overall survival of patients treated with this regimen.
• Determine distant brain recurrence in patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.
• Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo surgical resection of the metastatic brain lesion(s) followed by implantation of the GliaSite^® Radiation Therapy System (RTS). Beginning within the 21 days after surgical resection, patients undergo brachytherapy using the GliaSite^® RTS over 3-7 days. Patients with tumor(s) remaining after surgery also undergo stereotactic radiosurgery 14-42 days after surgical resection and after completion of brachytherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 1 and 3 months, and then every 3 months for 2 years.

Patients are followed at 1 and 3 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic carcinoma
• Stable systemic disease staged within the past 6 weeks
• No histology of lymphoma or small cell lung cancer
• Newly diagnosed supratentorial metastatic brain lesions
• One to three lesions with at least 1 dominant lesion that is amenable to surgical resection as visualized on enhanced MRI

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• No uncontrolled hypertension
• No unstable angina pectoris
• No evidence of uncontrolled cardiac dysrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other serious infection or medical illness that would preclude study therapy

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior polifeprosan 20 with carmustine implant (Gliadel^® wafer) for brain metastasis
• No prior temozolomide for brain metastasis

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent external-beam radiotherapy to the brain
• No concurrent whole-brain radiotherapy

Surgery

• Not specified

Other

• No other prior or concurrent conventional or investigational systemic agents for brain metastasis

Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting

Study chairs or principal investigators

Michael A. Vogelbaum, MD, PhD,  Study Chair,  Cleveland Clinic Cancer Center   

Study ID Numbers:  CDR0000378193; CCF-IRB-6675; CCF-CTSRC-1007; PROXIMA-CCF-IRB-6675; NCT00096252
Record last reviewed:  October 2004
Last Updated:  February 4, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096252
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08