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