NCT00019578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1998

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
Last Updated

October 31, 2023

Status Verified

March 1, 2012

First QC Date

March 1, 2007

Last Update Submit

October 27, 2023

Conditions

Adult Central Nervous System Germ Cell TumorAdult Malignant MeningiomaAdult MedulloblastomaAdult Noninfiltrating AstrocytomaAdult OligodendrogliomaAdult CraniopharyngiomaAdult MeningiomaBrain MetastasesAdult EpendymomaAdult Pineal Parenchymal TumorAdult Brain Stem GliomaAdult Infiltrating AstrocytomaMixed GliomasStage IV Peripheral Primitive Neuroectodermal Tumor

Keywords

adult brain stem gliomaadult brain tumoradult central nervous system germ cell tumoradult craniopharyngiomaadult ependymomaadult infiltrating astrocytomaadult malignant meningiomaadult medulloblastomaadult meningiomaadult noninfiltrating astrocytomaadult oligodendrogliomaadult pineal parenchymal tumoradult solid tumorbody system/site cancerbrain metastasesbrain tumorcancercentral nervous system cancergenetic conditionmetastatic cancermixed gliomassite, metastatic cancersolid tumorstage IV peripheral primitive neuroectodermal tumorstage/type, adult brain tumorunclassified/other cancer

Interventions

Sterotactic radiosurgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Radiation Oncology Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

MeningiomaMedulloblastomaOligodendrogliomaCraniopharyngiomaBrain NeoplasmsEpendymomaPinealomaGliomaNeuroectodermal Tumors, Primitive, PeripheralNeoplasmsCentral Nervous System NeoplasmsGenetic Diseases, InbornNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasms, Vascular TissueMeningeal NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialBrain DiseasesCentral Nervous System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian G. Fuller

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 2, 2007

Study Start

November 1, 1998

Study Completion

May 1, 2002

Last Updated

October 31, 2023

Record last verified: 2012-03

Locations

US(1)