NCT01727076

Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma, Kidney Cancer, Non-small Cell Lung Cancer, or Squamous Cell Head and Neck Cancer

Completed Phase 1 Last updated 15 September 2017

What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Head and Neck Squamous Cell Carcinoma in 20 participants. Completed in 30 June 2016.

Timeline

15 February 2013

Primary endpoint
30 June 2016

30 June 2016

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	15 February 2013
Primary completion	30 June 2016
Estimated completion	30 June 2016
Sites	5 locations across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• Pharmacological Study — full drug profile →
• Recombinant Human Interleukin-15 — full drug profile →

Conditions studied

• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• Recurrent Head and Neck Carcinoma — all drugs for Recurrent Head and Neck Carcinoma →
• Recurrent Non-Small Cell Lung Carcinoma — all drugs for Recurrent Non-Small Cell Lung Carcinoma →
• Recurrent Renal Cell Carcinoma — all drugs for Recurrent Renal Cell Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

19 and older, any sex, with Head and Neck Squamous Cell Carcinoma or Recurrent Head and Neck Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma, kidney cancer, non-small cell lung cancer, or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Recombinant interleukin-(IL)15 is a biological product, a protein, made naturally in the body and when made in the laboratory may help stimulate the immune system in different ways and stop tumor cells from growing.

Publications & conference data

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

1. 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
2. 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
3. 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
4. Phase I Trial of ALT-803, A Novel Recombinant IL15 Complex, in Patients with Advanced Solid Tumors.
   Margolin K, Morishima C, Velcheti V, Miller JS, et al · · 2018 · cited 164× · PMID 30045932 · DOI 10.1158/1078-0432.ccr-18-0945
5. 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
6. The IL-15-Based ALT-803 Complex Enhances FcγRIIIa-Triggered NK Cell Responses and In Vivo Clearance of B Cell Lymphomas.
   Rosario M, Liu B, Kong L, Collins LI, et al · · 2016 · cited 129× · PMID 26423796 · DOI 10.1158/1078-0432.ccr-15-1419
7. IL15 and T-cell Stemness in T-cell-Based Cancer Immunotherapy.
   Pilipow K, Roberto A, Roederer M, Waldmann TA, et al · · 2015 · cited 114× · PMID 26627006 · DOI 10.1158/0008-5472.can-15-1498
8. Utilizing cytokines to function-enable human NK cells for the immunotherapy of cancer.
   Romee R, Leong JW, Fehniger TA. · · 2014 · cited 99× · PMID 25054077 · DOI 10.1155/2014/205796