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

Sponsor
Pharmacyclics LLC. (Industry)
Overall Status
Completed
CT.gov ID
NCT00080054
Collaborator
(none)
24
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Motexafin Gadolinium Injection
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barrow Neurological Institute Phoenix Arizona United States 85013

    Sponsors and Collaborators

    • Pharmacyclics LLC.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00080054
    Other Study ID Numbers:
    • PCYC-0218
    First Posted:
    Mar 23, 2004
    Last Update Posted:
    Apr 3, 2009
    Last Verified:
    Jan 1, 2007

    Study Results

    No Results Posted as of Apr 3, 2009