Stereotactic Radiosurgery in Treating P… | Clinical Trial

Key information

Conditions

Adult Central Nervous System Germ Cell Tumor Adult Brain Stem Glioma Adult Craniopharyngioma Adult Ependymoma Adult Infiltrating Astrocytoma Adult Malignant Meningioma Adult Medulloblastoma Adult Meningioma Adult Noninfiltrating Astrocytoma Adult Oligodendroglioma Adult Pineal Parenchymal Tumor Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniopharyngioma Ependymoma Genetic Diseases, Inborn Glioma Medulloblastoma Meningeal Neoplasms Meningioma Mixed Gliomas Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Oligodendroglioma Pathologic Processes Pathological Conditions, Signs and Symptoms Pinealoma Stage IV Peripheral Primitive Neuroectodermal Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Radiation Oncology Branch

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sterotactic radiosurgery

Procedure

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Official study title

Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms

Important dates

Study start: 1998
Study completion: 2002
First posted: Mar 2, 2007
Registry last updated: Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed