Neural Stem Cell Preserving Brain Radiation Therapy & Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

This study has been terminated.
(New research priorities)
Sponsor:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00581113
First received: December 20, 2007
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

For patients with 1-6 intraparenchymal brain metastases from various primary histologies (except for melanoma), stereotactic radiosurgery (administered upfront or concurrently) or complete surgical resection with neural stem cell (NSC)-preserving whole-brain radiotherapy (WBRT) results in improved neurocognitive profile over standard WBRT. The goal of this study is to assess feasibility of this treatment approach.


Condition Intervention Phase
Lung Cancer
Breast Cancer
Prostate Cancer
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Neural Stem Cell (NSC) Preserving Whole Brain Radiation Therapy (WBRT) and Stereotactic Radiosurgery in Patients With 1-6 Brain Metastases

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI. [ Time Frame: 12 months post RT ] [ Designated as safety issue: No ]
    Brain metastases bi-dimensional area


Secondary Outcome Measures:
  • Increase in the Bi-dimensional Tumor Area for Any of the Tracked Brain Metastases or the Appearance of Any New Brain Metastases on a Follow-up MRI. [ Time Frame: 12 months after end of radiation therapy ] [ Designated as safety issue: No ]
    Increase in the bi-dimensional tumor area for any of the tracked brain metastases or the appearance of any new brain metastases on a follow-up MRI.


Enrollment: 8
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard Whole Brain Radiotherapy
Radiation: Radiotherapy
Treatments are delivered through parallel opposed or 5 degree RAO/LAO fields that cover the entire cranial contents. There should be beam fall-f of at least 1 cm. The eyes must be excluded from the beam either by field arrangement or shielding.
Experimental: 2
Neural Stem Cell-Preserving Whole Brain Radiotherapy
Radiation: Radiotherapy
Treatments are delivered through parallel opposed or 5 degree RAO/LAO fields that cover the entire cranial contents. There should be beam fall-f of at least 1 cm. The eyes must be excluded from the beam either by field arrangement or shielding.

Detailed Description:

Cancer patients (except patients with melanoma) with 1-6 brain metastases are randomized to receive standard whole brain radiation therapy or whole brain radiation therapy in a neural stem cell-preserving manner.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-melanoma primary malignancy with 1-6 intraparenchymal brain metastases (or small cell lung cancer being considered for prophylactic brain irradiation (PBI) with no demonstrable intracranial lesions).
  • A diagnostic contrast-enhanced magnetic resonance imaging (MRI) demonstrating the presence of 1-6 brain metastases performed within 4 weeks of registration. Note: If small cell lung cancer primary and patient being considered for PBI, MRI must demonstrate no intracranial lesions.
  • Patients with totally resected intraparenchymal brain metastases; not all lesions need be resected if all other criteria are satisfied (no more than 6 total lesions)
  • The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have maximum diameter of no more than 4 cm in any dimension on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter.
  • Metastatic lesions must be distributed peripherally, that is, at least 0.5 cm lateral (outside) of the lateral ventricles and/or hippocampus bilaterally. Posterior fossa metastatic lesions are allowed in the study.
  • Age 18 years or older.
  • Zubrod performance score 0-1.
  • Neurologic function score 0, 1, or 2.
  • Patients receiving glucocorticoids should be tapered to the lowest possible dose, or altogether, as judged by the participating physician. If glucocorticoid dose is adjusted or given for the first time, patient must remain on stable dose of glucocorticoids for at least 3 days prior to initial Neurocognitive Assessment Protocol (NAP), CT and MR imaging.

Exclusion Criteria:

  • Major medical illnesses or psychiatric impairments, which in the investigators opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
  • For patients who have undergone subtotal resection, residual disease must be 4 cm in maximum diameter.
  • Inability to obtain histologic proof of primary malignancy.
  • Patients with leptomeningial metastases documented by MRI or cerebral spinal fluid (CSF) evaluation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581113

Locations
United States, Virginia
Massey Cancer Center/Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Mitchell S. Anscher, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Mitchell S. Anscher, MD, Massey Cancer Center/Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00581113     History of Changes
Other Study ID Numbers: MCC-10655
Study First Received: December 20, 2007
Results First Received: October 6, 2010
Last Updated: January 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
whole brain radiotherapy
neural stem cell
brain metastases
radiosurgery

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014