Continuous Infusion of rhIL-15 for Adults With Advanced Cancer
- People with cancer can have a weak immune system as a result of the cancer itself, or from prior treatments. . Still, treatments that stimulate the immune system have been shown to be effective against a number of different cancers. Recombinant human interleukin-15 (rhIL-15) is a drug that is designed to boost the immune system. Researchers are interested in seeing if rhIL-15 can strengthen the immune system's response against cancer. The drug will be given through a vein without a break for 10 days (240 hours).
- To see rhIL-15 given as a continuous infusion over 10 days can be used to treat advanced cancer
- Identify the side effects associated with this treatment.
- Individuals at least 18 years of age with advanced cancer for which there are no effective treatments.
- Participants screening procedures will include a physical exam and medical history, laboratory (blood) tests and x-rays (Imaging studies) to determine suitability for the protocol. --Appropriate participants with easily accessible tumor deposits may also be asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy. .
- Eligible participants will be admitted to the hospital for the rhIL-15 treatment and will spend about 12 days in the hospital. .
- Participants will receive one 10 day infusion each cycle (about every 42 days) for as long as there are no serious side effects and the disease does not progress.
- Participants will continue treatment as long as imaging studies show that the tumor continues to shrink or for two additional cycles after it has disappeared from the x-rays to make that the cancer is completely gone.
- Participants who stop treatment for side effects or because their tumor did not shrink or stopped responding to the treatment will continue to have follow-up visits to monitor the outcome of the rhIL-15 treatment until there is evidence their cancer has progress or they begin another treatment.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of a Continuous Intravenous Infusion of Recombinant Human Interleukin IL-15 (rhIL-15) in Adults With Metastatic Cancers|
- Determine the safety, toxicity profile, DLT and MTD of IL-15 in subjects with metastatic cancers. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- Determine rhIL-15 PKs. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Characterize biological effects of rhIL-15 on T cells and NK cells and T-cells subsets. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Evaluate potential antitumor activity of rhIL-15. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Single-arm study
IL-15 IV for first 10 days of each 42 day cycle (dose of IL 15 will depend on current dose level at time of patient enrollment)
Drug: rh IL-15
IL-15 IV for first 10 days of each 42 day cycle
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|Contact: Tatyana Worthy, R.N.||(301) email@example.com|
|Contact: Kevin C Conlon, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Kevin C Conlon, M.D.||National Cancer Institute (NCI)|