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A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms Clinical research trials and A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms. A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms clinical trial. Human subjects often receive the most effective healthcare possible for their A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms  A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms
A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms
For Condition: Brain Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Stereotaxic Radiosurgery is the precise delivery of a single high hose of ionizing radiation to small (4 cm or less) intracranial targets with millimeter precision through the use of multiple tightly collimated radiation beams. It is well tolerated and can be performed as an outpatient procedure. In this pilot protocol we will utilize Radiosurgery for the treatment of intracranial neoplasms in order to establish experience with this technique in the ROB and at NIH. This pilot experience will form the basis of future protocols utilizing Stereotaxic Radiosurgery.
Details: Stereotaxic Radiosurgery is the precise delivery of a single high dose of ionizing radiation to small (4 cm or less) intracranial targets with millimeter precision through the use of multiple tightly collimated radiation beams. It is well tolerated and can be performed as an outpatient procedure. In this pilot protocol we will utilize Radiosurgery for the treatment of intracranial neoplasms in order to establish experience with this technique in the ROB and at NIH. This pilot experience will form the basis of future protocols utilizing Stereotaxic Radiosurgery.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Histologically documented intracranial tumor, pathologically documented cancer with metastases to the brain, or newly discovered lesion(s) which are amenable to stereotaxic biopsy. No tumor(s) greater than 4.0 cm. in diameter; and only one tumor greater than 3.0 cm. in diameter which is being considered for radiosurgery. Patients may have received prior cranial radiation, or previous Radiosurgery to other intracranial lesions. Patients having prior biopsy, subtotal or near-total resections are eligible. Patients must be greater than or equal to 18 years old. Radiologic evaluation (i.e., magnetic resonance imaging, MRI) must be obtained not greater than 4 weeks prior to initial evaluation. Patients must sign an informed consent and Durable Power of attorney statement after an in-depth discussion or risks, benefits, and treatment alternatives. Patients should have a life expectancy of greater than 3 months. Patients should have 3 or fewer measurable brain metastases requiring treatment. No patients with a performance status of less than 70 (Karnofsky) or greater than 2 (ECOG). Females must not be pregnant or lactating. Patients who for any reason are unable to have follow-up serial MRI scans (ie. due to logistics, non-compliance, contrast allergies or contraindications to MR scanning such as Aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto defibrillator; cochlear implant; ocular foreign body or implant (e.g. metal shavings, retinal clips); or Insulin pump) are excluded. Must not have a history of psychiatric disease sufficient to affect compliance with the protocol. Although patients should have an ECOG performance status equal to or less than 2, the presence of specific neurologic findings such as papilledema, or motor or sensory deficits will not constitute exclusion criteria. Patients cannot have had previous radiosurgery to the lesion being considered for treatment on study. Must not have tumors in the center of the brain stem for those which involve greater than 50% of the brain stem. Patients with clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgement of the Principal Investigator would compromise the patient's ability to tolerate this therapy or are likely to interfere with the study procedures or results are excluded.
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990011; 99-C-0011
Study Start Date: November 3, 1998
Record last reviewed: May 6, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001791
Other Brain Neoplasm Studies:
1. Safety and tolerability study of 131I-TM-601 to treat adult patients with recurrent glioma.
2. A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms
3. A Pilot Study of 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Pediatric Patients with Primary and Metastatic Brain Tumors
4. Gene Therapy for the Treatment of Brain Tumors
5. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
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Other Brain Neoplasm Clinical Trials
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A Pilot Study of Stereotaxic Radiosurgery for Intracranial Neoplasms
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