Radiation Therapy in Treating Patients Who Are Undergoing Surgery to Remove a Metastatic Brain Tumor

NeuroTherapia, Inc.

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Metastatic Cancer

Treatments: Procedure: conventional surgery; Radiation: intraoperative radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00107367

CCF-510K

CCF-IRB-7003

CCF-K992577

CDR0000378144

CCF-CTSRC-1065

Details and patient eligibility

About

RATIONALE: Specialized radiation therapy that delivers radiation directly to the area where a tumor was surgically removed may kill any remaining tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying radiation therapy to see how well it works in treating patients who are undergoing surgery to remove a metastatic brain tumor.

Full description

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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