An Evaluation of Safety and Efficacy of Escalating Doses of AMD3100 to Mobilize CD34+ Cells in Healthy Volunteers
Status:
Completed
Trial end date:
2015-01-23
Target enrollment:
Participant gender:
Summary
This study will determine how safely and well people can tolerate AMD3100 at larger than
normal doses to mobilize CD34+ cells, (stem cells). AMD3100 is a new drug designed to
mobilize stem cells for transplantation in cancer patients. It pushes those cells into the
circulation, making it easier to collect them, and it temporarily increases the number of
stem cells in a person's blood.
Patients ages 18 to 50 in good health and who are not pregnant or breastfeeding may be
eligible for this study. They will undergo the following tests and procedures:
- History and physical examination
- Review of medications, including those prescribed and over-the-counter, as well as
nutritional supplements
- Blood tests for liver, kidneys, and other functions; and for infections including
hepatitis and AIDS
- Pregnancy test
- Electrocardiogram
On the day they receive AMD3100, patients will be admitted to the Clinical Center. They will
receive two doses, injected under the skin, at intervals separated by 14 to 90 days. Dose
levels are 240 and 320 micrograms/kg and 400 and 480 micrograms/kg. For 24 hours following
the first AMD3100 administration, blood will be collected periodically through a plastic tube
at amounts dependent on doses of AMD3100 given. If patients receive one of the two highest
doses, their heart rhythm will be monitored continuously during the hospital stay. From 7 to
10 days following administration of AMD3100, patients will give blood samples to monitor the
effects. The second dose of AMD3100 will be given 14 to 90 days after the first one. Patients
will return to the Clinical Center for the same procedures as done previously, but the dose
of the drug will be higher.
Risks involve side effects of AMD3100. In previous studies, patients who received the drug
experienced a temporary increase in white blood cell counts. Serious side effects have
included abnormally low platelet clot, abnormal heart rhythm, and low blood pressure.
Patients will be carefully monitored for such effects.