Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmacyclics LLC.
Treatments:
Motexafin gadolinium
Temozolomide
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