Trial · NCT01572493
Continuous Infusion of rhIL-15 for Adults With Advanced Cancer
NCT01572493, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Continuous Infusion of rhIL-15 for Adults With Advanced Cancer. Trials, record NCT01572493. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01572493
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continuous Infusion of rhIL-15 for Adults With Advanced Cancer
- NCT number
- NCT01572493
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 38 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma, Carcinoma
- Interventions
- rh IL-15 (10 DAYS), rh IL-15 (5 DAYS)
- First posted
- 2012-04-06
- Last updated
- 2023-03-06
- Results first posted
- 2023-03-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 10 Day Dosing | 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. Grade 3 is severe, and Grade 4 is life-threatening. |
| Primary | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 5 Day Dosing | After one cycle (one cycle is 21 days for 5-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. Grade 3 is severe, and Grade 4 is life-threatening. |
| Primary | Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | 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. |
| Secondary | Clinical Response Rate | 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 new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Time to Progression (TTP) | 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. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Recombinant Human Interleukin-15 (rhIL-15) | 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. |
| Secondary | Concentration of Drug in Plasma at Steady State (Css) | Days 7 through 10 | Concentration of drug in plasma at steady state (Css). |
| Secondary | Area Under the Curve (AUClast) | 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. |
| Secondary | Inflammatory Cytokines | 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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 one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 10 Day Dosing | After one cycle (one cycle is 42 days for 10-day dosing) | mcg/kg/day | NUMBER | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 5 Day Dosing | After one cycle (one cycle is 21 days for 5-day dosing) | mcg/kg/day | NUMBER | |
| PRIMARY | Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | After one cycle (one cycle is either 42 or 21 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Response Rate | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Progression (TTP) | From the date of protocol consent until date of progressive disease is documented, up to 263 days | One participant in dose level 1 and dose level 2, two participants in dose level 3, three participants in dose level 4, two participants in dose level 5, one participant in dose level 6 and dose level 7, and one participant in dose level 9 were not evaluable. | Days | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Recombinant Human Interleukin-15 (rhIL-15) | 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. | 3/4 participants in dose level 1, and 2/3 participants in dose level 2 were not evaluable for this outcome measure. Cmax was only performed for the 10 day dosing cohorts. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Concentration of Drug in Plasma at Steady State (Css) | Days 7 through 10 | 3/4 participants in dose level 1, and 2/3 participants in dose level 2 were not evaluable for this outcome measure. Css was only performed for the 10 day dosing cohorts. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve (AUClast) | 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. | 3/4 participants in dose level 1, and 2/3 participants in dose level 2 were not evaluable for this outcome measure. AUClast was only performed for the 10 day dosing cohorts. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Inflammatory Cytokines | 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. | This outcome measure was only performed for 10 day dosing. | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group614
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 10 Day Dosing | All Participants | 2 | mcg/kg/day | ||
| Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin-15 (rhIL-15) for 5 Day Dosing | All Participants | NA | mcg/kg/day | ||
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | Grade 3 | 2 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days | Grade 3 | 0 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days | Grade 3 | 0 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days | Grade 3 | 1 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days | Grade 3 | 0 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days | Grade 3 | 0 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days | Grade 3 | 0 | Participants | |
| Number of Participants With Grades 3, 4 or 5 Dose-Limiting Toxicity (DLT) Related to Study Drug | Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days | Grade 3 | 0 | Participants |
1 to 10 of 614Source ClinicalTrials.gov
See all 614 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | 4 | |
| Overall Study | STARTED | Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days | 3 | |
| Overall Study | STARTED | Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days | 3 | |
| Overall Study | STARTED | Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days | 6 | |
| Overall Study | STARTED | Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days | 9 | |
| Overall Study | STARTED | Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days | 2 | |
| Overall Study | STARTED | Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days | 4 | |
| Overall Study | STARTED | Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days | 3 | |
| Overall Study | STARTED | Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days | 4 | |
| Overall Study | COMPLETED | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events1,485
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | 1 | 4 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days | 0 | 6 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days | 1 | 9 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days | 1 | 2 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days | 1 | 4 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | 1 | 4 | 2 |
1 to 10 of 1,485Source ClinicalTrials.gov
See all 1,485 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | 0 | 4 |
| Total, all-cause mortality | Dose Escalation Level 2 - 0.25 mcg/kg/Day x 10 Days | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Level 3 - 0.5 mcg/kg/Day x 10 Days | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Level 4 - 1 mcg/kg/Day x 10 Days | 1 | 6 |
| Total, all-cause mortality | Dose Escalation Level 5 - 2 mcg/kg/Day x 10 Days | 0 | 9 |
| Total, all-cause mortality | Dose Escalation Level 6 - 4 mcg/kg/Day x 10 Days | 1 | 2 |
| Total, all-cause mortality | Dose Escalation Level 7 - 3 mcg/kg/Day x 5 Days | 0 | 4 |
| Total, all-cause mortality | Dose Escalation Level 8 - 4 mcg/kg/Day x 5 Days | 0 | 3 |
| Total, all-cause mortality | Dose Escalation Level 9 - 5 mcg/kg/Day x 5 Days | 0 | 4 |
| Total, other adverse events | Dose Escalation Level 1 - 0.1 mcg/kg/Day x 10 Days | 4 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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