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

Pharmacyclics LLC.24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioma Glioblastoma Astrocytoma Oligodendroglioma Brain Neoplasm

Interventions

Motexafin Gadolinium InjectionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Barrow Neurological Institute

Phoenix, Arizona, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.