Status:
COMPLETED
Ultra Low Dose Interleukin-2 in Healthy Volunteers
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hematologic Diseases
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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 disorder...
Detailed Description
Interleukin 2 (IL-2, aldesleukin) was discovered as a T cell growth factor more than 30 years ago. IL-2 was the first human cytokine used therapeutically. IL-2 induces antigen specific T cells, and tw...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy volunteers confirmed by brief history and physical examination and blood work through the CHI screening protocol
- Males or females ages 18 years or older
- EXCLUSION CRITERIA:
- History of inflammatory or autoimmune disease
- History of inflammatory or autoimmune disease in first degree relatives
- History of malignancies
- Recipients of hematopoietic stem cell transplant or solid organ transplant
- History of seizures
- Positive HIV, hepatitis B surface antigen or hepatitis C antibody
- History or clinical signs of cardiac disease including coronary artery disease, cardiac arrhythmia, congestive heart failure
- History or clinical signs of of pulmonary disease including obstructive lung disease and asthma
- Active infections requiring systemic antibiotic therapy or anti-viral therapy
- History of systemic fungal or mycobacterial infections
- Use of immune modifying medications, i.e.- non steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen, celecoxib, ketrolac), steroid (prednisone, dexamethasone, hydrocortisone), chemotherapy (cisplatin, dacarbazine, interferon alpha, tamoxifen)
- Persons who are alcoholic or abusers of illicit drugs
- Female subjects who are or may be pregnant or lactating
- Psychiatric diagnoses or symptoms, to include hypomania, bipolar disorder, major depression, or dysthymia
- Abnormal or marginal peripheral blood count that in the opinion of the PI will cause Hemoglobin and Hematocrit levels to drop as a result of participation in this study
- Liver function tests above the normal laboratory reference range
- Renal function test above the normal laboratory reference range
- Contraindication to interleukin-2 (i.e. hypersensitivity to IL- 2 products, active coronary artery disease, patients with organ allograft)
- Recent recipient of any type of vaccination (i.e. rotavirus vaccine, BCG, influenza virus vaccine, rubella virus vaccine, mumps virus vaccine, measles vaccine, poliovirus vaccine, smallpox vaccine, typhoid vaccine, varicella virus vaccine, yellow fever vaccine) in the 4 weeks preceding and during active study participation
- Body mass index greater than 35
- Inability to comprehend the investigational nature of the study or provide informed consent
- Diabetes mellitus or fasting blood glucose of \> 100 mg/dL.
- Any drugs or supplements that interfere with blood clotting such as Vit.E, NSAIDS, Warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix)
- Use of iodinated contrast media in the 4 weeks preceding and during active study participation.
Exclusion
Key Trial Info
Start Date :
September 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01445561
Start Date
September 28 2011
End Date
July 15 2013
Last Update
March 16 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892