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

This study has been completed.

Sponsor:

Information provided by:

Pharmacyclics

ClinicalTrials.gov Identifier:

NCT00080054

First received: March 22, 2004

Last updated: April 2, 2009

Last verified: January 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2004
Last Updated Date	April 2, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
Official Title ^ICMJE	Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas
Brief 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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glioma Glioblastoma Astrocytoma Oligodendroglioma Brain Neoplasm
Intervention ^ICMJE	Drug: Motexafin Gadolinium Injection
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00080054
Other Study ID Numbers ^ICMJE	PCYC-0218
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Pharmacyclics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pharmacyclics
Verification Date	January 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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