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Initial Recurrence of Glioblastoma Multiforme
A PHASE 2 STUDY OF MEDI-575 IN ADULT SUBJECTS WITH RECURRENT GLIOBLASTOMA (IRB #24347)
MEDI-575 is an experimental drug used to treat patients who have recurrent glioblastoma multiforme (GBM) a type of brain cancer. MEDI-575 is an antibody(natural protein found in the body) that attaches tightly to other proteins and molecules and, under normal circumstances, helps fight infection. MEDI-575 works by attaching (like a lock and key) to PDGFRα on cells, including cells that are part of the cancer, and stopping the protein’s activity. MEDI-575 is being studied to see if it might slow the cancer’s growth or stop it from spreading to other parts of the body.
The study will see if MEDI-575 has any effect on the cancer. The study will also measure how much MEDI-575 is in the blood when the drug is given and the body’s response to treatment with MEDI-575. The study will also test whether the immune cells in the body create antibodies to MEDI-575. The information learned in this study may be helpful in further developing MEDI-575 for the treatment of GBM.
Patients at least 18 years of age and who have a confirmed diagnosis of Grade IV malignant glioma (glioblastoma) and who have had a previous treatment with the standard of care for this diagnosis; radiotherapy(radiation) and temozolomide (a type of chemotherapy)and have documented recurrent glioblastoma on a diagnostic biopsy or as assessed by contrast enhanced MRI are potential candidates for participation in this study.
Patients seen in the department of Neurology at CSMC or referred by an outside physician who meet all inclusion criteria will be given the informed consent and allowed ample time to read and ask questions before making a decision to participate. The consent process will be done with the study investigator or co-investigator.
Eligible patients will be given 25 mg/kg (25 milligrams per kilogram or per 2.2 pounds of body weight) of MEDI-575 by 60-minute intravenous (by vein) infusion on Day 1 and every 21 days. Patients will come to the study site once a week beginning 1 week after their first dose of MEDI-575 and again the week after. For each cycle after Cycle 1, they will come to the study site once every 21 days. Patients may continue to receive MEDI-575 unless their disease gets worse or they experience intolerable side effects. Participants will be asked not to take any other experimental drugs or vaccines during the entire study from the time they sign the informed consent form until the final visit, unless their doctor considers it medically necessary. Patients will also come to the study site at the end of their treatment, and every 3 months after that until the study ends. We estimate patients will be in the study for 21 months, based on expecting to meet target recruitment at 1 year. The study end date will be marked 9 months after that.
Required Archived Tumor Sample
Archived (stored) specimens will be requested to assess certain tumor-specific markers. Participants must agree to allow access to these samples to participate in this trial.
Optional Fresh Tumor Sample
Participants will be asked to provide a fresh tumor sample following discontinuation of treatment with MEDI-575 and any other procedures related to this research study, but before the start of another anti-cancer therapy. This sample will be obtained via biopsy for additional testing by MedImmune. This sample will only be obtained if a biopsy will be conducted as part of standard of care.
Sub-Study for Future Use of Specimens
The study sponsor, MedImmune would like to keep blood and tumor tissue specimens that are left over from the study for future research.
Sub-Study for DNA Testing
The study sponsor, MedImmune would like to collect an extra sample of blood for DNA analysis (genetic testing).
INFORMATION RELATED TO THE COLLECTION OF PREGNANCY OUTCOME DATA
Pregnant women and children will not be eligible to receive the study intervention. Involvement of pregnant women will be limited to the adverse event in which a female subject (partner of male subject) becomes pregnant during the course study. If a woman (partner of male subject) becomes pregnant during the course of the research, information regarding the pregnancy as well as information regarding the outcome of her pregnancy will be monitored for research purposes. As the monitoring will be limited to obtaining data related to the course of the pregnancy and birth outcomes, there are no physical risks for pregnant woman and the newborns whose medical records may be reviewed. The collection of such information poses no greater than minimal risk for these populations and is described in the consent form. Consent/parental permission to review the medical records will be obtained from the pregnant women via the study consent form.
Surasak Phuphanich, MD, FAAN
Director, Neuro-oncology Program
Christy Davis, RN