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Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms

Phase 1
18 Years
Not Enrolling
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

Thank you

Trial Information

Phase I Pilot Study of Stereotaxic Radiosurgery in Patients With Intracranial Neoplasms

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.


Up to 30 patients will be accrued for this study within 7-10 months.

Inclusion 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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian G. Fuller

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

November 1998

Completion Date:

May 2002

Related Keywords:

  • 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
  • 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
  • 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



Radiation Oncology Branch Bethesda, Maryland  20892