NT-I7 for Kaposi Sarcoma in Patients With or Without HIV (NCT04893018) | Clinical Trial Compass
TerminatedPhase 1
NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
Stopped: Terminated due to end of funding
United States8 participantsStarted 2022-05-23
Plain-language summary
This phase I trial studies the best dose and effects of NT-I7 in treating Kaposi sarcoma in patients with or without HIV. NT-I7 works by using a patient's immune system to fight cancer. It is made in a laboratory and is used to boost, direct, or restore the body's natural defenses against cancer. NT-I7 may work better in treating Kaposi sarcoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed Kaposi sarcoma
* Patients must have evaluable disease. Note: Kaposi sarcoma will be evaluated using a modified version (consistent with National Cancer Institute \[NCI\] studies) of the Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) Oncology Committee staging and response definitions for KS
* No upper or lower limit on the number of prior therapies or stage of disease
* HIV-positive patients must have been on effective anti-retroviral (ART) therapy for at least 3 months prior to enrollment, with persistent KS affecting quality of life due to either T1 disease or T0 disease with inadequate disease regression on ART alone
* HIV-positive patients must have undetectable HIV viral loads =\< 40 copies/mL measured using a Food and Drug Administration (FDA)-approved commercial assay with lower limit of detection between =\< 20 copies/mL and =\< 40 copies/mL
* Patients with visceral involvement must:
* Meet other eligibility criteria
* Have any/all associated tumor associated symptoms =\< grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) criteria; and/or
* Require no immediate intervention (e.g. mild oozing of oral KS not an exclusion criteria)
* Patients must provide newly obtained core, punch, or excisional biopsy of a tumor lesion obtained up to 28 days prior to treatment initiation. An archival tumor sample obtained within 1 year of screening is allowed if pre treatment…
What they're measuring
1
Percentage of Participants With Adverse Events
Timeframe: Up to 30 days after last dose of NT-I7, approximately 31 weeks total