A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas - Full Text View

Purpose

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.

Condition	Intervention	Phase
Glioma Glioblastoma Astrocytoma Oligodendroglioma Brain Neoplasm	Drug: Motexafin Gadolinium Injection	Phase I

MedlinePlus related topics:

Brain Cancer Cancer

ChemIDplus related topics:

Temozolomide Motexafin gadolinium Motexafin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

24

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080054

Locations


United States, Arizona
	Barrow Neurological Institute
	Phoenix, Arizona, United States, 85013

Sponsors and Collaborators

Pharmacyclics

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	PCYC-0218
First Received:	March 22, 2004
Last Updated:	January 30, 2007
ClinicalTrials.gov Identifier:	NCT00080054
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacyclics:

Malignant Glioma

Glioblastoma multiforme

GBM

Anaplastic astrocytoma

AA

Anaplastic oligodendroglioma

Anaplastic mixed glioma

Brain tumor

Brain neoplasm

Glioma

Study placed in the following topic categories:

Glioblastoma

Astrocytoma

Central Nervous System Diseases

Central Nervous System Neoplasms

Motexafin gadolinium

Brain Diseases

Temozolomide

Brain Neoplasms

Neuroectodermal Tumors

Glioblastoma multiforme

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Oligodendroglioma

Glioma

Nervous System Neoplasms

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Neoplasms, Nerve Tissue

Nervous System Diseases

Pharmacologic Actions

Neoplasms

Photosensitizing Agents

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

Antineoplastic Agents, Alkylating

Neoplasms, Neuroepithelial

Dermatologic Agents

Alkylating Agents

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Pharmacyclics
Information provided by:	Pharmacyclics
ClinicalTrials.gov Identifier:	NCT00080054