Ultra Low Dose Interleukin-2 in Healthy Volunteers

NCT01445561 | Completed Phase 1

• 2 other identifiers: 11026811-H-0268
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hematologic Diseases

Keywords

Interleukin-2; IL-2; Stem Cells; Regulatory T Cells (T regs); Natural Killer Cells (NK cells); Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of ultra low dose IL-2. TRSAE rate of no more than 5% would allow us to proceed with future studies.

  To determine the safety and the tolerability of ultra low dose (physiologic dose) interleukin-2 in healthy volunteers

  28 days

Secondary Outcomes (1)

• Human immune response (immunome) to ultra low dose IL-2 based on research lab assessments

  28 days

Study Arms (2)

1

EXPERIMENTAL

100,000 international units/m2 SQ daily for 5 days

Drug: Interleukin-2 (100,00 IU/m(2) SQ)

2

EXPERIMENTAL

200,000 international units/m2 SQ daily for 5 days

Drug: Interleukin-2 (100,00 IU/m(2) SQ)

Interventions

Interleukin-2 (100,00 IU/m(2) SQ) DRUG

100,000 International Units/m2 SQ daily for 5 days

1; 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Smith KA. Interleukin-2: inception, impact, and implications. Science. 1988 May 27;240(4856):1169-76. doi: 10.1126/science.3131876.

  PMID: 3131876 BACKGROUND

• Morgan DA, Ruscetti FW, Gallo R. Selective in vitro growth of T lymphocytes from normal human bone marrows. Science. 1976 Sep 10;193(4257):1007-8. doi: 10.1126/science.181845.

  PMID: 181845 BACKGROUND

• Macdonald D, Jiang YZ, Gordon AA, Mahendra P, Oskam R, Palmer PA, Franks CR, Barrett AJ. Recombinant interleukin 2 for acute myeloid leukaemia in first complete remission: a pilot study. Leuk Res. 1990;14(11-12):967-73. doi: 10.1016/0145-2126(90)90109-m.

  PMID: 2280612 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Chen Zhao, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 3, 2011
• Study Start: September 28, 2011
• Primary Completion: July 15, 2013
• Study Completion: July 15, 2013
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

US (1)