Stereotactic Radiosurgery in Treating Patients With Brain Tumors

Official Title: “Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms”

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of stereotactic radiosurgery in treating patients who have brain tumors.

OBJECTIVES: I. Establish stereotaxic radiosurgery as a treatment technique at the National Institute of Health in patients with intracranial neoplasms.

II. Assess the response rate, local control, time to progression, pattern of failure, and magnetic resonance spectrographic data following this therapy in these patients.

PROTOCOL OUTLINE: All patients undergo stereotaxic head frame placement, followed by stereotaxic radiosurgery on day 1. The dosage of radiation therapy administered is dependent on the tumor diameter.

Patients are followed at 2 and 6 weeks and then every 3 months for 5 years.

PROJECTED ACCRUAL:

Up to 30 patients will be accrued for this study within 7-10 months.

Intervention(s) in this Clinical Trial

• Procedure: Sterotactic radiosurgery

PROTOCOL ENTRY CRITERIA:

• -Disease Characteristics-- Histologically proven intracranial tumor OR Pathologically confirmed cancer with metastases to the brain OR Newly discovered brain lesions that are amenable to stereotaxic biopsy No more than 3 measurable tumors Only 1 tumor more than 3 cm in diameter that requires radiosurgery allowed No tumor more than 4 cm in diameter No tumor that involves more than 50% of the brain stem --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: Prior cranial radiotherapy allowed Surgery:
• Radiosurgery to other nonstudy intracranial lesions allowed Prior biopsy and/or subtotal or near-total resection allowed --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 70-100% OR ECOG 0-2 Life expectancy: More than 3 months Hematopoietic:
• WBC at least 3,000/mm3 Absolute granulocyte count at least 500/mm3 Hemoglobin at least 10 g/dL Platelet count at least 50,000/mm3 Hepatic: SGOT or SGPT no greater than 2.5 times upper limit of normal (ULN) PT and PTT no greater than 1.5 times ULN No clinically significant hepatic dysfunction Renal: Creatinine no greater than 1.3 times ULN
• Cardiovascular: No clinically significant cardiac dysfunction Pulmonary: No clinically significant pulmonary dysfunction Other: Not pregnant or nursing Negative pregnancy test
• No clinically significant systemic illness or serious infection that would preclude study compliance No other organ dysfunction that would preclude study compliance No history of psychiatric disease No allergy to contrast agent Papilledema and motor or sensory deficits allowed No contraindications to MRI (e.g., aneurysm clip, implanted neural stimulator, implanted cardiac defibrillator, cochlear implant, ocular foreign body or implant, or insulin pump)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Investigator: National Cancer Institute (NCI) NIH

Overall Clinical Trial Officials and Contacts

Brian G. Fuller Study Chair National Cancer Institute (NCI)  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00019578

Study ID Number: CDR0000066758

ClinicalTrials.gov Identifier: NCT00019578

Health Authority: United States: Federal Government