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Investigator(s):
Kevin Conlon, M.D. Principal Investigator Phone: 301-496-7417 Fax: 301-402-1001 conlonkc@mail.nih.gov
Referral Contact(s):
Tat’Yana Worthy, R.N. Research Nurse Specialist Phone: 301-496-0499 worthyt@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed solid tumor malignancy or lymphoma
• Metastatic or unresectable
• Standard curative or palliative measures do not exist or are associated with minimal patient survival benefit (as defined by the Metabolism Branch physicians or if the patient refuses standard of care treatment)
• Completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, not a candidate for therapy of proven efficacy, or patient refused standard of care treatment
• ≥ 18 years of age
• Measurable or evaluable disease
• Karnofsky performance ≥ 70% or ECOG ≤ 1
• Adequate organ function as defined by liver, kidney, and hematologic laboratory testing
• No active central nervous system (CNS) metastases; but treated, inactive CNS metastases (≥ 3 months stability on MRI after treatment) are permitted
• No concurrent major medical illnesses or any form of immunodeficiency

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Study Outline:

• Dose escalation trial with treatment given as an inpatient at the National Institutes of Health Clinical Center unit; participants will be in the hospital about 12 days to receive their treatment
• Treatment is a 10-day (240-hour) continuous infusion of rhIL-15 during each cycle (about every 42 days) for as long as there are no serious side effects and the disease does not progress
• Screening with physical examination, blood samples, and imaging studies to determine eligibility for the study
• Appropriate participants with easily accessible tumor deposits may also be asked to have one pretreatment and one post (cycle 1) treatment tumor biopsy
• Cycles continue for as long as X-ray studies show evidence of continuing response or for two additional cycles after the tumor has disappeared completely from the X-rays
• Participants who stop treatment for side effects or because their tumor did not respond or stopped responding to the treatment will have regular follow-up visits to monitor their disease until there is evidence their cancer has progressed or they begin another treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 5/17/12