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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00121420
First received: July 14, 2005
Last updated: September 11, 2012
Last verified: May 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Neoplasm Metastasis
Brain Neoplasms
 Drug: Motexafin gadolinium
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occurring within 3 months following SRS boost.

Secondary Outcome Measures:
  • Change in lesion size and number between screening MRI and SRS treatment-planning MRI
  • Time to neurologic progression or death with evidence of neurologic progression
  • Time to neurocognitive progression
  • Time to all-cause mortality

Estimated Enrollment: 45
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121420

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, Colorado
Aurora, Colorado, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Canada, Quebec
Montreal, Quebec, Canada
Quebec City, Quebec, Canada
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Pharmacyclics
Investigators
Study Chair: Minesh P Mehta, MD University of Wisconsin, Madison
  More Information

Additional Information:
National Brain Tumor Foundation  This link exits the ClinicalTrials.gov site
Pharmacyclics  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Pharmacyclics
ClinicalTrials.gov Identifier: NCT00121420     History of Changes
Other Study ID Numbers: PCYC-0224
Study First Received: July 14, 2005
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacyclics:
Brain Neoplasms/secondary
Brain neoplasms/radiotherapy
Brain metastasis
Neoplasm metastasis
Cranial irradiation
Radiosurgery
 Lung Neoplasms
Breast Neoplasms
Kidney Neoplasms
Melanoma
Radiotherapy
Carcinoma, non-small cell lung

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neoplastic Processes
Pathologic Processes
Motexafin gadolinium
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on October 16, 2012