drugset / 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
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-02-15
- Primary completion
- 2016-06-30
- Completion
- 2016-06-30
Publications
- Margolin K, Morishima C, Velcheti V, Miller JS, Lee SM, Silk AW, Holtan SG, Lacroix AM, Fling SP, Kaiser JC, Egan JO, Jones M, Rhode PR, Rock AD, Cheever MA, Wong HC, Ernstoff MS. Phase I Trial of ALT-803, A Novel Recombinant IL15 Complex, in Patients with Advanced Solid Tumors. Clin Cancer Res. 2018 Nov 15;24(22):5552-5561. doi: 10.1158/1078-0432.CCR-18-0945. Epub 2018 Jul 25.
- Miller JS, Morishima C, McNeel DG, Patel MR, Kohrt HEK, Thompson JA, Sondel PM, Wakelee HA, Disis ML, Kaiser JC, Cheever MA, Streicher H, Creekmore SP, Waldmann TA, Conlon KC. A First-in-Human Phase I Study of Subcutaneous Outpatient Recombinant Human IL15 (rhIL15) in Adults with Advanced Solid Tumors. Clin Cancer Res. 2018 Apr 1;24(7):1525-1535. doi: 10.1158/1078-0432.CCR-17-2451. Epub 2017 Dec 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rhIL-15 | Protein / enzyme biologic | 0.25 ug/kg | Subcutaneous |
| Subject | rhIL-15 | Protein / enzyme biologic | 0.5 ug/kg | Subcutaneous |
| Subject | rhIL-15 | Protein / enzyme biologic | 1 ug/kg | Subcutaneous |
| Subject | rhIL-15 | Protein / enzyme biologic | 2 ug/kg | Subcutaneous |
| Subject | rhIL-15 | Protein / enzyme biologic | 3 ug/kg | Subcutaneous |