Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
H. Lee Moffitt Cancer Center and Research Institute
With
Each Cycle is a 21 day period. On the first day of each cycle each patient will receive the study drug, ZK-Epo, through an IV infusion over a 3 hour period. Patients will receive the study drug only once every 21 day period. At the start of each cycle patients will have the following tests: * Patients will be asked questions about their medical history and health and undergo a complete physical exam. * Blood tests will be done to check blood cell count and organ functions (about 1 tablespoon of blood will be taken). * Performance status tests (will determine patient's ability to perform everyday functions). * A nurse or doctor will ask patients how they are feeling and about any side effects that patients may be having. * Pre Study Visit: Blood test called lactate dehydrogenase (LDH) to check organ function. Prothrombin time (PT) and an a partial thromboplastin time (PTT) to see if the patient's blood clots normally. Electrocardiogram (EKG) (to measure the electrical function of patient's heart). Pregnancy Test (IF APPLICABLE a woman of child bearing age). Optional Tumor Biopsy (If indicated by patient's physician). * Cycle 1, Day 1: Pharmacokinetics: special blood tests to measure the drug levels, LDH * Cycle 1, Day 2 \& 8: Pharmacokinetics * Cycle 1, Day 15: EKG * Cycle 2, DAY 1: LDH * Cycle 3, DAY 1: LDH, PT \& activated partial thromboplastin time (aPTT) * Cycle 4, 5, \& 6, and all subsequent cycles, Day 1: LDH During the first cycle only patients will also need to come for a study visit on day 8 and 15. During these two visits, blood tests will be done again to check blood cell count and organ functions. Patients will also be asked how they are feeling and about any side effects that they may be having. Computed tomography (CT) scans or a magnetic resonance imaging (MRI) will be done after every 2 cycles that each patient completes on the study. These will be done to help the doctor re-evaluate each patient's disease. Patients may have some additional blood tests done if they are among the first 10 patients taking part in this study. In this case they will have 9 samples of blood (each about a teaspoonful) drawn from them at specifically timed intervals (at 30 minutes before the start and at 30 minutes, 2 hour 55 minutes, 3 hour 10 minutes, 3 hour 30 minutes, 5 hour, 8 hour, 27 hour (+/- 1 hour) and 168 hour (+/- 4 hours) after the start of the ZK-Epo infusion) so that we can better understand the level of this drug in the body and its metabolism in people.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
