Trial · NCT01727076
Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer
NCT01727076, Phase 1, Completed, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer. Trials, record NCT01727076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01727076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer
- NCT number
- NCT01727076
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma, Recurrent Non-Small Cell Lung Carcinoma, Recurrent Renal Cell Carcinoma, Recurrent Skin Carcinoma, Stage III Renal Cell Cancer, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIB Non-Small Cell Lung Cancer AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7, Stage IV Non-Small Cell Lung Cancer AJCC v7, Stage IV Renal Cell Cancer
- Interventions
- Laboratory Biomarker Analysis, Pharmacological Study, Recombinant Human Interleukin-15
- First posted
- 2012-11-15
- Last updated
- 2017-09-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD defined as the next lower dose in which 1 or more patients experiences a dose limiting toxicity defined as grade 3 or 4 toxicity graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 | 28 days | |
| Secondary | ALC, monitored daily during treatment | Up to 6 months | The absolute increase in each cell subset as well as the variance in change across each dose level (mean, median, and SE/SD will be reported for each dose level and ALC, circulating NK count, and circulating CD4/CD8 cell counts). |
| Secondary | Change in NK cell function measured using flow cytometric analysis of cytokine (IFN-y) secretion and expression of degranulation marker CD107a | Baseline to day 15 | The absolute change in responses for each patient will be calculated by subtracting the SFC/million PBMC at day 11 from the SFC/million PBMC at baseline for each antigen. |
| Secondary | Change in presence of auto-antibodies, assessed by ELISA | Baseline to day 4 of week 2 | The number and percentage of patients developing auto-antibodies to IL15 will be tabulated by dose cohort. |
| Secondary | Change in T cell responses to non- physiologic stimuli including PMA | Baseline to day 4 of week 2 | The absolute change in responses for each patient will be calculated by subtracting the SFC/million PBMC at day 11 from the SFC/million PBMC at baseline for each antigen. |
| Secondary | Change in T cell subset response to recall viral antigens including CMV and influenza A virus, determined by enzyme-linked immunosorbent spot assay | Baseline to day 4 of week 2 | The absolute change in responses for each patient will be calculated by subtracting the spot forming cells (SFC)/million peripheral blood mononuclear cell (PBMC) at day 11 from the SFC/million PBMC at baseline for each antigen. |
| Secondary | Change in total number of T cells and NK cells, as well as activated T cells, T cell subsets, and NK cell subsets, assessed by flow cytometric analysis of peripheral blood mononuclear cells | Baseline to day 15 | The percentage of cells positive for the marker and/or mean fluorescence intensity (MFI) at time points after rhIL15 administration will be compared to baseline and the change will be calculated as %after/ %baseline or MFI after/ MFI baseline. |
| Secondary | ORR based on RECIST criteria | Up to day 56 (after 2 courses) | Percentages and exact 2-sided 95% confidence intervals of the numbers in each of the overall response categories (complete response, partial response, stable disease and progressive disease) will be calculated for each dose cohort. |
| Secondary | Serum PK of IL15 and IL15 receptor-alpha, assessed by enzyme linked immunosorbent assay (ELISA) | Pre-dose, and 10 minutes, 1, 4, and 24 hours after administration | IL15 and IL15 receptor-alpha levels will be plotted over time for each dose group. |
| Secondary | Total white blood cell count, monitored daily during treatment | Up to 6 months | The absolute increase in each cell subset as well as the variance in change across each dose level (mean, median, and standard error \[SE\]/standard deviation \[SD\] will be reported for each dose level and absolute lymphocyte count \[ALC\], circulating NK count, and circulating CD4/CD8 cell counts). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01CA154967 | Cancer Immunotherapy Trials Network Central Operations and Statistical Center | CHEEVER, MARTIN ALEXANDER | FRED HUTCHINSON CANCER RESEARCH CENTER | NATIONAL CANCER INSTITUTE | 2010 to 2017 |
Source NIH RePORTER
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01727076
GET https://conductscience.org/api/trials/v1/NCT01727076/registered