Stereotactic Radiosurgery in Treating Patients With Brain Tumors

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00019578
First received: March 1, 2007
Last updated: March 21, 2012
Last verified: March 2012
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Study Start Date: November 1998
Study Completion Date: May 2002
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00019578     History of Changes
Obsolete Identifiers: NCT00001791
Other Study ID Numbers: 990011, 99-C-0011, CDR0000066758
Study First Received: March 1, 2007
Last Updated: March 21, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
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

Additional relevant MeSH terms:
Astrocytoma
Brain Neoplasms
Craniopharyngioma
Adamantinoma
Ependymoma
Glioma
Medulloblastoma
Meningioma
Neoplasm Metastasis
Oligodendroglioma
Pinealoma
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Neuroepithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on August 28, 2014