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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121420
Recruitment Status : Terminated
First Posted : July 21, 2005
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasm Metastasis Brain Neoplasms Drug: Motexafin gadolinium Phase 2

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  (Clinical Trial)
Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

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

Secondary Outcome Measures :
  1. Change in lesion size and number between screening MRI and SRS treatment -planning MRI
  2. Time to neuroligic progression or death with evidence of neurologic progression
  3. Time to neurocognitive progression

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121420

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

Additional Information:
Responsible Party: Pharmacyclics LLC. Identifier: NCT00121420     History of Changes
Other Study ID Numbers: PCYC-0224
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents