NCT01572493 is a Phase 1 clinical trial of rh IL-15 (10 DAYS) in Lymphoma, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT01572493?

NCT01572493 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01572493?

Interventions in NCT01572493: rh IL-15 (10 DAYS), rh IL-15 (5 DAYS).

What condition does NCT01572493 study?

NCT01572493 studies Lymphoma, Carcinoma.

Is NCT01572493 still recruiting?

NCT01572493 is currently completed. Last updated 6 March 2023.

Are results published for NCT01572493?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-06 · How we verify

NCT01572493

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Continuous Infusion of rhIL-15 for Adults With Advanced Cancer

Completed Phase 1 Results posted Last updated 6 March 2023

What this trial tests

Phase 1 trial testing rh IL-15 (10 DAYS) in Lymphoma in 38 participants. Completed in 2 July 2019.

Timeline

4 April 2012

Primary endpoint
20 June 2019

2 July 2019

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	4 April 2012
Primary completion	20 June 2019
Estimated completion	2 July 2019
Sites	1 location across United States

Drugs / interventions tested

rh IL-15 (10 DAYS) — full drug profile →
rh IL-15 (5 DAYS) — full drug profile →

Conditions studied

Lymphoma — all drugs for Lymphoma →
Carcinoma — all drugs for Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Lymphoma or Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 10 Day Dosing Primary · After one cycle (one cycle is 42 days for 10-day dosing)

The MTD is the dose level at which less than one-third of patients (0/3 or 0-1/6 participants) treated at that dose experience a dose-limiting toxicity (DLT), with the next higher dose level demonstrating a one-third or greater number of participants (≥ 2/3 or ≥ 2/6 participants) having DLT. A DLT is Grade 2 diarrhea lasting more than 24 hours or any grade 3 or 4 toxicity, if deemed possibly, probably or definitely related to the study drug by the principal investigator during the first cycle of treatment. Toxicities were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4

Group	Value	95% CI
All Participants	2

Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 5 Day Dosing Primary · After one cycle (one cycle is 21 days for 5-day dosing)

Group	Value	95% CI
All Participants	NA

Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug Primary · After one cycle (one cycle is either 42 or 21 days)

A DLT is Grade 2 diarrhea lasting more than 24 hours or any grade 3 or 4 toxicity, if deemed possibly, probable or definitely related to the study drug by the principal investigator during the first cycle of treatment; and/or Grade 5 death related to adverse event. Toxicities were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v4. Grade 3 is severe, and Grade 4 is life-threatening.

Grade 3

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	2
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	1
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	0
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	0
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	0
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	0

Grade 4

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	2
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	0
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	1
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	0
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	0
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	0

Grade 5

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	0
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	1
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	0
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	0
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	0

Clinical Response Rate Secondary · Both cycles 1 and 2 (each cycle is 42 days) for the 10 day treatment, up to 84 days. And clinical responses for the 5-day treatment cohorts (21 day cycle length) were assessed after cycles 2, 4, 6, 8 and so on treatment cycles.

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and the appearance of one or more

Complete Response

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	0
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	0
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	0
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	0

Partial Response

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	0
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	0
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	0
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	0

Progressive Disease

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	1
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	3
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	1
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	2
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	3
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	2
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	1
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	2
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	3

Stable Disease

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	2
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	2
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	3
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	4
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	2
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	1
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	0

Not Assessed

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	1
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	1
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	2
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	1
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	0
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	1

Time to Progression (TTP) Secondary · From the date of protocol consent until date of progressive disease is documented, up to 263 days

TTP is defined as the date of protocol consent until date of progressive disease is documented. Progressive disease was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, and the appearance of one or more new lesions.

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	74	28 – 138
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	54	37 – 71
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	29	NA – NA
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	77	70 – 263
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	68	30 – 74
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	6	NA – NA
Dose Escalation Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	87	49 – 91
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	42	42 – 74
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	34.5	9 – 42

Maximum Observed Plasma Concentration (Cmax) of Recombinant Human Interleukin-15 (rhIL-15) Secondary · Prior to 1st dose, at 10 minutes after 1st dose, once daily on days 7-10 at completion of treatment, at 10 and 30 minutes after completion of treatment and at 1, 2, 4, and approximately 24 hours after completion of treatment.

The maximum observed analyte concentration in serum was reported.

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	51	± NA
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	59	± NA
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	116	± 72
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	1413	± 1478
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	5662	± 5961
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	26852	± 11374

Concentration of Drug in Plasma at Steady State (Css) Secondary · Days 7 through 10

Concentration of drug in plasma at steady state (Css).

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	44.5	± NA
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	48.5	± NA
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	73.2	± 22.6
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	489	± 463
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	2020	± 2309
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	9562	± 59.35

Area Under the Curve (AUClast) Secondary · Prior to 1st dose, at 10 minutes after 1st dose, once daily on days 7-10 at completion of treatment, at 10 and 30 minutes after completion of treatment and at 1, 2, 4, and approximately 24 hours after completion of treatment.

AUClast is from dosing to the time of the last measured concentration \>/= lower limit of quantitation (LLOQ)(Clast) of that dosing period.

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	7756	± NA
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	10907	± NA
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	20798	± 8667
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	187453	± 206143
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	321747	± 300686
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	262651	± 77613

Inflammatory Cytokines Secondary · Pre, 0.16, 1, 2, 4, 8, 12, and 24 hours on Day 1. Days 2, 7, 8, 9, and 10. 0, 0.16, 0.32, 1, 2, 4, and 12 hours on Day 11. And 24 hours on Day 12.

Serum samples was obtained from participants and inflammatory cytokine analyses was performed by flow cytometry to determine levels of Interleukin - 1, Interferon γ, Interleukin-6 and Tumor Necrosis Factor ἁ.

Interleukin - 1, Pre Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.38	± 0.24
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	9.8	± 15.9
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0.86	± 0.8
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	0.34	± 0.1
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Interleukin - 1, 0.16 hours on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.28	± 0
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	2.2	± 3
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	19	± 45
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	77	± 229
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Interleukin - 1, 1 hour on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.47	± 0.3
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	17.9	± 30
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	9.1	± 20
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	57	± 170
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Interleukin - 1, 2 hours on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.58	± 0.3
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	4.4	± 6.8
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	3.5	± 8
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	22	± 65
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Interleukin - 1, 4 hours on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.59	± 0.3
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	13.4	± 21
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0.53	± 0.3
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	6.3	± 16
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.36	± 0.2

Interleukin - 1, 8 hours on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.73	± 0.1
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	1.3	± 1.4
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0.83	± 0.8
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	209	± 605
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Interleukin - 1, 12 hours on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.54	± 0.2
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0.36	± 0.2
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	0.5	± 0.3
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	7	± 19.7
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Interleukin - 1, 24 hours on Day 1

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	0.36	± 0.2
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	0.24	± 0
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	0.62	± 0.65
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	1.2	± 1.4
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	4.3	± 8
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	0.24	± 0

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) Secondary · Date treatment consent signed to date off study, approximately 18 months (m)/27 days(d), 3 m, 9 m/13d, 15 m/20d, 28 m/17d, 1 m/23d, 15 m/8d, 4 m/5d, and 6 m/30d for levels 1-9 respectively.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent

Group	Value	95% CI
Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days	4
Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days	3
Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days	3
Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days	6
Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days	9
Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days	2
Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days	4
Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days	3
Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Date treatment consent signed to date off study, approximately 18 months and 27 days for level 1, 3 months for level 2, 9 months and 13 days for level 3, 15 months and 20 days for level 4, 28 months and 17 days for level 5, 1 month and 23 days for level 6, 15 months and 8 days for level 7, 4 months and 5 days for level 8, and 6 months and 30 days for level 9.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days

Serious: 2/4 (50%)

Deaths: 0/4

Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days

Serious: 1/3 (33%)

Deaths: 0/3

Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days

Serious: 1/3 (33%)

Deaths: 0/3

Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days

Serious: 3/6 (50%)

Deaths: 1/6

Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days

Serious: 2/9 (22%)

Deaths: 0/9

Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days

Serious: 2/2 (100%)

Deaths: 1/2

Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days

Serious: 0/4 (0%)

Deaths: 0/4

Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days

Serious: 1/3 (33%)

Deaths: 0/3

Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days

Serious: 2/4 (50%)

Deaths: 0/4

Serious adverse events (31 terms)

Reaction	System	Dose Escalation Level 1 - …	Dose Escalation Level 2 - …	Dose Escalation Level 3 - …	Dose Escalation Level 4 - …	Dose Escalation Level 5 - …	Dose Escalation Level 6 - …	Dose Escalation Level 7 - …	Dose Escalation Level 8 - …	Dose Escalation Level 9 - …
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—
Bronchopulmonary hemorrhage	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Capillary leak syndrome	Vascular disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Duodenal hemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Edema face	General disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gastrointestinal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Infections and infestations - Other, Recurrent retropharyngeal infection/abscess	Infections and infestations	—	—	—	—	—	—	—	—	—
Investigations - Other, Direct bilirubin	Investigations	—	—	—	—	—	—	—	—	—
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Multi-organ failure	General disorders	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Nervous system disorders - Other, Cord compression	Nervous system disorders	—	—	—	—	—	—	—	—	—

Other adverse events (134 terms — click to expand)

Reaction	System	Dose Escalation Level 1 - …	Dose Escalation Level 2 - …	Dose Escalation Level 3 - …	Dose Escalation Level 4 - …	Dose Escalation Level 5 - …	Dose Escalation Level 6 - …	Dose Escalation Level 7 - …	Dose Escalation Level 8 - …	Dose Escalation Level 9 - …
Alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—	—	—	—
Lymphocyte count increased	Investigations	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—
White blood cell decreased	Investigations	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Bloating	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Creatinine increased	Investigations	—	—	—	—	—	—	—	—	—
Edema limbs	General disorders	—	—	—	—	—	—	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypomagnesemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—
Edema face	General disorders	—	—	—	—	—	—	—	—	—
Flushing	Vascular disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—
Blurred vision	Eye disorders	—	—	—	—	—	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Alanine aminotransferase increased, Anemia, Arthritis, Aspartate aminotransferase increased, Atrial fibrillation, Bronchopulmonary hemorrhage, Capillary leak syndrome.

Data from ClinicalTrials.gov NCT01572493 adverse events section.

Sponsor's own description

Background: \- 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). Objectives: * 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. Eligibility: \- Individuals at least 18 years of age with advanced cancer for which there are no effective treatments. Design: * 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Natural killer cells in cancer biology and therapy.
Wu SY, Fu T, Jiang YZ, Shao ZM. · · 2020 · cited 640× · PMID 32762681 · DOI 10.1186/s12943-020-01238-x
Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
The tumor microenvironment in esophageal cancer.
Lin EW, Karakasheva TA, Hicks PD, Bass AJ, et al · · 2016 · cited 245× · PMID 26923327 · DOI 10.1038/onc.2016.34
Continuous treatment with IL-15 exhausts human NK cells via a metabolic defect.
Felices M, Lenvik AJ, McElmurry R, Chu S, et al · · 2018 · cited 210× · PMID 29415897 · DOI 10.1172/jci.insight.96219
Molecular pathways: interleukin-15 signaling in health and in cancer.
Mishra A, Sullivan L, Caligiuri MA. · · 2014 · cited 182× · PMID 24737791 · DOI 10.1158/1078-0432.ccr-12-3603
Tumor-related interleukins: old validated targets for new anti-cancer drug development.
Setrerrahmane S, Xu H. · · 2017 · cited 173× · PMID 28927416 · DOI 10.1186/s12943-017-0721-9
Anticancer Cytokines: Biology and Clinical Effects of Interferon-α2, Interleukin (IL)-2, IL-15, IL-21, and IL-12.
Floros T, Tarhini AA. · · 2015 · cited 170× · PMID 26320059 · DOI 10.1053/j.seminoncol.2015.05.015
The potential and promise of IL-15 in immuno-oncogenic therapies.
Robinson TO, Schluns KS. · · 2017 · cited 155× · PMID 28823521 · DOI 10.1016/j.imlet.2017.08.010

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01572493 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 6 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01572493.

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NCT01572493

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (31 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Lymphoma

Other National Cancer Institute (NCI) trials

Verify against primary sources