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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioma Glioblastoma Astrocytoma Oligodendroglioma Brain Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Motexafin Gadolinium Injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No