Ultra Low Dose Interleukin-2 in Healthy Volunteers
Status:
Completed
Trial end date:
2013-07-15
Target enrollment:
Participant gender:
Summary
Background:
- Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High
dose interleukin-2 has been used to treat different types of cancer and immune system
disorders. However, it can cause frequent and often serious side effects at the doses
currently used for treatment. Very low dose interleukin-2 (700 folds less than regular dose)
was previously tested in cancer patients and stem cell transplant recipients. The study
observed important immune changes and minimal side effects in those patients. Researchers
want to test the healthy immune system's responses to very low doses of interleukin-2 to
better understand how the drug works.
Objectives:
- To study the effects of very low doses of interleukin-2 on healthy volunteers.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a medical history and physical exam. They will also
have blood and urine samples.
- Participants will receive one of two possible very low doses of interleukin-2 every day
for 5 days.
- Blood samples will be taken twice before the first dose, 1 day after the first dose, and
before the next three doses. Followup blood samples will be taken on Days 7, 14, and 28
after the first dose.