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

This study has been completed.

First Received on March 22, 2004. Last Updated on April 2, 2009 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Temozolomide Motexafin gadolinium Motexafin

U.S. FDA Resources

Further study details as provided by Pharmacyclics:

Estimated Enrollment:

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00080054 History of Changes
Other Study ID Numbers:	PCYC-0218
Study First Received:	March 22, 2004
Last Updated:	April 2, 2009
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

Additional relevant MeSH terms:

Astrocytoma
Brain Neoplasms
Neoplasms
Glioblastoma
Glioma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Temozolomide
Motexafin gadolinium
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012