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

April 2, 2009 updated by: Pharmacyclics LLC.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 22, 2004

First Submitted That Met QC Criteria

March 22, 2004

First Posted (Estimate)

March 23, 2004

Study Record Updates

Last Update Posted (Estimate)

April 3, 2009

Last Update Submitted That Met QC Criteria

April 2, 2009

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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