Clinical trial NCT00019578: Stereotactic Radiosurgery in Treating Patients With Brain Tumors
Official title: Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adult Central Nervous System Germ Cell Tumor
Adult Malignant Meningioma
Adult Medulloblastoma
Adult Noninfiltrating Astrocytoma
Adult Oligodendroglioma
Adult Craniopharyngioma
Adult Meningioma
Brain Metastases
Adult Ependymoma
Adult Pineal Parenchymal Tumor
Adult Brain Stem Glioma
Adult Infiltrating Astrocytoma
Mixed Gliomas
Stage IV Peripheral Primitive Neuroectodermal Tumor
Keywords: adult brain stem glioma
adult brain tumor
adult central nervous system germ cell tumor
adult craniopharyngioma
adult ependymoma
adult infiltrating astrocytoma
adult malignant meningioma
adult medulloblastoma
adult meningioma
adult noninfiltrating astrocytoma
adult oligodendroglioma
adult pineal parenchymal tumor
adult solid tumor
body system/site cancer
brain metastases
brain tumor
cancer
central nervous system cancer
genetic condition
metastatic cancer
mixed gliomas
site, metastatic cancer
solid tumor
stage IV peripheral primitive neuroectodermal tumor
stage/type, adult brain tumor
unclassified/other cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2007-03-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Radiation Oncology Branch
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Brian G. Fuller
role: STUDY_CHAIR
References: