Clinical Trial: A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas

This study is currently recruiting patients.

Sponsored by: Pharmacyclics
Information provided by: Pharmacyclics

Purpose

The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.

Condition Treatment or Intervention Phase
Glioma
Glioblastoma
Astrocytoma
Oligodendroglioma
Brain Neoplasm
 Drug: Motexafin Gadolinium Injection
Phase I

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 I Trial of Motexafin Gadolinium (MGd) in Combination with Temozolomide for Treatment of Malignant Gliomas

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

Laboratory values of:

  • Absolute neutrophil count < 2000/µL
  • Platelet count < 100,000/µL
  • AST or ALT > 2 x the upper limit of normal (ULN)
  • Alkaline phosphatase > 5 x ULN
  • Bilirubin > 2 x ULN
  • Creatinine > 2.0 mg/µL

and

  • Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
  • Women who are pregnant or lactating

Location and Contact Information

France Bui, MD      877-676-0330    MedicalAffairs@pcyc.com
Cindy Cheng, PharmD      877-676-0330    MedicalAffairs@pcyc.com

Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States; Recruiting
William R Shapiro, MD  602-456-7890 
Greta Ludwig, PA, C
William R Shapiro, MD,  Principal Investigator

More Information

http://www.braintumor.org

http://www.pcyc.com

Study ID Numbers:  PCYC-0218
Record last reviewed:  March 2004
Last Updated:  October 25, 2004
Record first received:  March 22, 2004
ClinicalTrials.gov Identifier:  NCT00080054
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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