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Stereotactic Radiosurgery in Treating Patients With Brain Tumors

Primary Purpose

Adult Central Nervous System Germ Cell Tumor, Adult Malignant Meningioma, Adult Medulloblastoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sterotactic radiosurgery
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Central Nervous System Germ Cell Tumor focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)

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)

Sites / Locations

  • Radiation Oncology Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 1, 2007
Last Updated
March 21, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00019578
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Sterotactic radiosurgery

10. Eligibility

Minimum Age & Unit of Time
18 Years
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian G. Fuller
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Radiation Oncology Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Stereotactic Radiosurgery in Treating Patients With Brain Tumors

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