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

Study Identifier
PCYC-0218
CT.gov Identifier
NCT00080054
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Cancer - Other
  • Brain Cancer
    • Study Drug
  • Motexafin Gadolinium Injection
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * At least 18 years old * Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma) * ECOG performance status score of 0, 1, or 2 * Each patient must sign a study-specific informed consent form
    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

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Barrow Neurological Institute
    Phoenix, Arizona, United States, 85013
    Status
    Not applicable