Anja[a]
A PHASE II TRIAL OF TARCEVA IN PATIENTS WITH RECURRENT/PROGRESSIVE GLIOBLASTOMA MULTIFORME
Conditions:
Prior Surgery is Allowed
Prior Radiation is Allowed
Prior Chemotherapy is Allowed
The purpose of the research study is to learn about whether a new experimental drug, OSI-774 (also called Tarceva) will show efficacy against malignant brain tumors that are Histologically confirmed WHO grade IV astrocytoma (glioblastoma multiforme), with radiographic evidence of recurrence. Research over the past 15 years has led to the discovery of specific control systems for tumor cell division and tumor growth which are abnormally turned on in malignant brain tumors. A new class of investigational drugs has been developed that are specifically designed to block the growth signals for the brain tumor cells. OSI-774 is an investigational drug being tested in patients with malignant primary brain tumors after initial treatment with surgery, radiation and/or chemotherapy. OSI-774 is a drug designed to block a signal from the molecule called epidermal growth factor receptor (EGFR), which drives brain tumor cells to divide uncontrollably. EGFR is overexpressed in approximately 40% of tumors. OSI-774 may have its best activity in those 40%. It is not known what effect it will have on other tumors. This is a Phase II study, which means that the goal is to see if the study treatment shows any efficacy when given at the highest dose found to be safe in previous studies. The investigators hope to learn whether other patients with your disease might benefit from treatment with OSI-774. No one knows whether the treatment you receive will have any effect on your tumor.
Comments: Trial participants will undergo a number of tests to be certain that they are healthy except for their tumor. Participants will have blood tests to measure how many white blood cells, red blood cells and platelets they have and also the function of their liver and kidneys. Prior to participation they will also have a physical and neurological exam, and a brain MRI scan. Participants will receive OSI-774 by mouth once daily every day. The duration of the treatment is mostly dependent upon the participants' survival; therefore this treatment with OSI-774 will continue as long as participants remain in this study. Reasons for discontinuing participation in the study include tumor growth, unacceptable side effects from OSI-774 or participant's voluntary withdrawal from the study. While receiving OSI-774, participants will undergo a physical and neurologic exam, and will have 2-3 tablespoons of blood drawn every month during the first year of treatment. After the first year of treatment, these exams and blood draws will be performed every 2 months until treatment is discontinued. Also, while receiving OSI-774, participants will have an MRI scan done every 3 months until you discontinue treatment. If the participant is female of child-bearing potential, they must have a negative pregnancy test prior to starting treatment with OSI-774. If the participant is male and wishes to have children in the future, they have the option of storing their sperm. Participants must inform their doctors of any other medications you are taking, including over the counter medicines, herbal therapies or medicines, or other alternative therapies. There may be interactions between drugs and it is important that doctors know what the participants are taking.
Contact:
Michael Vogelbaum M.D., Ph.D.
Director, Center for Translational Therapeutics
Cleveland Clinic Foundation
Brain Tumor Institute / ND40
9500 Euclid Avenue
Cleveland, OH 44195 USA
Phone: 216-444-8564
Fax: 216-444-9170
E-mail: vogelbm@neus.ccf.org