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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 - Article


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Clinical Trial: Study of Motexafin Gadolinium with Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients with Brain Metastases

This study is currently recruiting patients.

Sponsored by: Pharmacyclics
Information provided by: Pharmacyclics

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 II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  45

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 above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00121420

France Bui, MD      877.676.0330    MedicalAffairs@pcyc.com

Arizona
      Phoenix,  Arizona,  United States; Recruiting

Colorado
      Aurora,  Colorado,  United States; Not yet recruiting

Ohio
      Cleveland,  Ohio,  United States; Recruiting

      Columbus,  Ohio,  United States; Recruiting

Pennsylvania
      Philadelphia,  Pennsylvania,  United States; Recruiting

Texas
      Dallas,  Texas,  United States; Not yet recruiting

      Houston,  Texas,  United States; Not yet recruiting

Wisconsin
      Madison,  Wisconsin,  United States; Recruiting

      Milwaukee,  Wisconsin,  United States; Not yet recruiting

Canada, Quebec
      Montreal,  Quebec,  Canada; Recruiting

      Sherbrooke,  Quebec,  Canada; Recruiting

      Quebec City,  Quebec,  Canada; Recruiting

Study chairs or principal investigators

Minesh P Mehta, MD,  Study Chair,  University of Wisconsin-Madison   

More Information

Publications

Mehta MP, Rodrigus P, Terhaard CH, Rao A, Suh J, Roa W, Souhami L, Bezjak A, Leibenhaut M, Komaki R, Schultz C, Timmerman R, Curran W, Smith J, Phan SC, Miller RA, Renschler MF. Survival and neurologic outcomes in a randomized trial of motexafin gadolinium and whole-brain radiation therapy in brain metastases. J Clin Oncol. 2003 Jul 1;21(13):2529-36.

Evens AM. Motexafin gadolinium: a redox-active tumor selective agent for the treatment of cancer. Curr Opin Oncol. 2004 Nov;16(6):576-80. Review.

Biaglow JE. The thioredoxin reductase/thioredoxin system: novel redox targets for cancer therapy. Cancer Biol Ther. 2005 Jan;4(1):6-13. Epub 2004 Jan 8.

Manon R, Hui S, Chinnaiyan P, Suh J, Chang E, Timmerman R, Phan S, Das R, Mehta M. The impact of mid-treatment MRI on defining boost volumes in the radiation treatment of glioblastoma multiforme. Technol Cancer Res Treat. 2004 Jun;3(3):303-7.

Meyers CA, Smith JA, Bezjak A, Mehta MP, Liebmann J, Illidge T, Kunkler I, Caudrelier JM, Eisenberg PD, Meerwaldt J, Siemers R, Carrie C, Gaspar LE, Curran W, Phan SC, Miller RA, Renschler MF. Neurocognitive function and progression in patients with brain metastases treated with whole-brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol. 2004 Jan 1;22(1):157-65.

Study ID Numbers:  PCYC-0224
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 20, 2005
ClinicalTrials.gov Identifier:  NCT00121420
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26


Source: ClinicalTrials.gov
Cache Date: July 27, 2005


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