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Stereotactic Radiosurgery in Treating Patients With Brain Tumors
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019578
  Purpose

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.


Condition Intervention Phase
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
Procedure: Sterotactic radiosurgery
Phase I

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1998
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

Ages Eligible for Study:   18 Years and older
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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019578

Locations
United States, Maryland
Radiation Oncology Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Brian G. Fuller National Cancer Institute (NCI)
  More Information

Study ID Numbers: CDR0000066758, NCI-99-C-0011
Study First Received: March 1, 2007
Last Updated: March 1, 2007
ClinicalTrials.gov Identifier: NCT00019578  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult pineal parenchymal tumor
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 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

Study placed in the following topic categories:
Meningeal Neoplasms
Neuroectodermal Tumors, Primitive
Astrocytoma
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Ependymoma
Brain Neoplasms
Neuroectodermal Tumors
Peripheral neuroectodermal tumor
Neoplasms, Germ Cell and Embryonal
Craniopharyngioma
Neoplasm Metastasis
Medulloblastoma
Neuroepithelioma
Oligodendroglioma
Meningioma
Glioma
Pinealoma
Nervous System Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009