Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas
Data Collection
Astrocytoma+15
+ Brain Diseases
+ Brain Neoplasms
Treatment Study
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location