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NCT00080054 Clinical Trial

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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00080054
Other study ID # PCYC-0218
Secondary ID
Status Completed
Phase Phase 1
First received March 22, 2004
Last updated April 2, 2009

Study information
Verified date January 2007
Source Pharmacyclics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Motexafin Gadolinium Injection

Locations
Country Name City State
United States Barrow Neurological Institute Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Pharmacyclics

Country where clinical trial is conducted

United States, 

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