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Sponsored by: |
Pharmacyclics |
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Information provided by: | Pharmacyclics |
ClinicalTrials.gov Identifier: | NCT00080054 |
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 |
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Glioma Glioblastoma Astrocytoma Oligodendroglioma Brain Neoplasm |
Drug: Motexafin Gadolinium Injection |
Phase I |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory values of:
and
Study ID Numbers: | PCYC-0218 |
Study First Received: | March 22, 2004 |
Last Updated: | January 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00080054 |
Health Authority: | United States: Food and Drug Administration |
Malignant Glioma Glioblastoma multiforme GBM Anaplastic astrocytoma AA |
Anaplastic oligodendroglioma Anaplastic mixed glioma Brain tumor Brain neoplasm Glioma |
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 |
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 |