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 terminated.
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT00121420
First received: July 14, 2005
Last updated: May 7, 2014
Last verified: May 2014

July 14, 2005
May 7, 2014
Not Provided
Not Provided
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
Not Provided
Complete list of historical versions of study NCT00121420 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasm Metastasis
  • Brain Neoplasms
Drug: Motexafin gadolinium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00121420
PCYC-0224
Not Provided
Pharmacyclics
Pharmacyclics
Not Provided
Study Chair: Minesh P Mehta, MD University of Wisconsin, Madison
Pharmacyclics
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP