Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

May 7, 2014 updated by: Pharmacyclics LLC.

Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will receive three weeks of whole brain radiation therapy concurrent with daily motexafin gadolinium during weeks 2 and 3, followed by a stereotactic radiosurgery boost concurrent with motexafin gadolinium. Patients will be followed for radiologic response, neurologic progression, and neurocognitive progression.

Study Type

Interventional

Enrollment

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Quebec City, Quebec, Canada
      • Sherbrooke, Quebec, Canada
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • Colorado
      • Aurora, Colorado, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Wisconsin
      • Madison, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Karnofsky performance status (KPS) ≥ 70
  • Histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases
  • Each patient must sign a study-specific Informed Consent form

Exclusion Criteria:

  • Previous cranial radiation
  • Complete resection of all known brain metastases
  • Known leptomeningeal metastases
  • Known liver metastases
  • Clinical or radiologic evidence of progression (other than study lesion[s) within 1 month prior to enrollment
  • Patients with metastases within 10 mm of the optic apparatus
  • Patients with metastases in the brainstem, midbrain, pons, or medulla
  • Planned chemotherapy during WBRT and/or SRS
  • Uncontrolled hypertension
  • Women who are pregnant or lactating

and Laboratory values as follows:

  • LDH > 1.3 x upper limit of normal (ULN)
  • ANC < 1500/mm3
  • Platelets < 50,000/mm3
  • Creatinine > 2.0 mg/dL
  • AST or ALT > 3 x ULN
  • Total bilirubin > 2 x ULN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost

Secondary Outcome Measures

Outcome Measure
Change in lesion size and number between screening MRI and SRS treatment -planning MRI
Time to neuroligic progression or death with evidence of neurologic progression
Time to neurocognitive progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Investigators

  • Study Chair: Minesh P Mehta, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 14, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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