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

NCT00581113 | Terminated Phase 3 Results DMC

• 1 other identifier: MCC-10655
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Breast Cancer; Prostate Cancer

Keywords

whole brain radiotherapy; neural stem cell; brain metastases; radiosurgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Brain metastases bi-dimensional area

  12 months post RT

Secondary Outcomes (1)

• 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.

  12 months after end of radiation therapy

Study Arms (2)

1

ACTIVE COMPARATOR

Standard Whole Brain Radiotherapy

Radiation: Radiotherapy

2

EXPERIMENTAL

Neural Stem Cell-Preserving Whole Brain Radiotherapy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Massey Cancer Center/Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Brain Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Trial not completed. Insufficient data to analyze.

Results Point of Contact

• Title: Martha D. Wellons
• Organization: Virginia Commonwealth University

mwellons@vcu.edu

804-628-1939

Study Officials

• Mitchell S. Anscher, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 11, 2015
• Results First Posted: February 24, 2011

Record last verified: 2015-05

Locations

US (1)