Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-response (REGIMEN-KS HIV)
Background: Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Having HIV can weaken the immune system and this can lead to KS. Weaker immune systems may be measured by low T cells (a type of immune cell). CYT107 is a human protein, made in a laboratory, that may help boost immunity, specifically by increasing T cells, in people with HIV-associated KS.
Objective: To see if CYT107 can shrink KS tumors.
Eligibility: People aged 18 years and older with HIV-associated KS.
Design: Participants will be screened. They will have a physical exam with blood tests. Their skin lesions will be measured. They will have an x-ray of their lungs. Their ability to perform everyday tasks will be reviewed. A sample of lesion tissue (biopsy) may be collected from the skin. CYT107 is injected into the muscle of the arm, buttocks, or lower thigh once a week for up to 4 weeks. Participants will receive the shots at the clinic. Blood and other tests will be repeated at each visit. KS lesions will be measured and photographed on the 1st and 4th visits. Participants who improved after the first 4 weeks may have another 4-week treatment within a year. Follow-up visits will continue for 3 years.
• Histologically confirmed KS by NCI Laboratory of Pathology (LP), with or without any prior systemic KS treatment
• Participants with HIV infection
• Age \>= 18 years
• All participants should have at least five (5) measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.
• Participants with stage T1 KS with visceral involvement must:
‣ have any/all associated tumor associated symptoms \<= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 criteria and/or,
⁃ require no immediate intervention (e.g., mild oozing of oral KS is allowed).
• Participants did not receive prior systemic therapy for KS or received prior systemic therapy and currently are either plateau in response, relapsed disease, progressive disease (PD), or inadequate response to treatment. Note: Previous local therapy or radiation is not considered systemic therapy.
• Participants must:
‣ have been on effective ART therapy for at least 2 months prior to the study drug initiation and
⁃ have HIV VL \<= 100 copies/mL and
⁃ have persistent KS, affecting quality of life due to either T1 or T0 disease with inadequate disease regression on ART alone.
• ECOG PS \<=3
• Adequate organ and marrow function as defined below:
‣ absolute neutrophil count (ANC) \>= 500/mcL
⁃ platelets \>= 50,000/mcL
⁃ hemoglobin (hgb) \>= 8g/dL
⁃ total bilirubin \<= 1.5 institutional upper limit of normal (iULN) or \<3 x iULN for Gilbert s syndrome or HIV protease inhibitors
• AST \<= 2.5 x iULN
• ALT \<= 2.5 x iULN
• CD4 T-cell count \<= 350/mcL
• Participants must be willing to co-enroll to protocol 17C0174 Molecular Characterization of Viral-associated Tumors, Tumors occurring in the Setting of HIV or other Immune Disorders and Castleman Disease
• Participants with chronic hepatitis B virus (HBV) infection are eligible if they are on suppressive antiviral therapy.
• Participants with a hepatitis C virus (HCV) infection must have an undetectable HCV VL due to prior treatment or natural resolution.
• Women of child-bearing potential (WOCBP) and men able to father a child must agree to use an effective method of contraception (hormonal, barrier, surgical sterilization, abstinence) at the study entry, for the duration of study therapy, and for up to 4 months
∙ after discontinuation of study drug.
• Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug.
• Participants must be able to understand and willing to sign a written informed consent document.