Table 1.
Systemic cell-mediated immunotherapies in clinical development in head and neck cancer [40].
| Agent | Phase | Status | Study Type | Description |
|---|---|---|---|---|
| IFN-α | 2 (NCT00004897) | Active, not recruiting (N ~ 15–45) | Open-label trial | Patients with stage I–III esophageal cancer receive combination chemotherapy and recombinant IFN-α followed by surgery and/or RT |
| 3 (NCT00054561) | Completed (N = 376) | Multicenter randomized controlled trial | To compare the combination of isotretinoin, recombinant IFN-α, and vitamin E with observation only in patients with stage III or IV HNSCC | |
|
| ||||
| Pegylated IFN-α2b | 2 (NCT00276523) | Completed (N = 72) | Randomized controlled trial | Pegylated IFN-α2b at 3 different dose levels is compared with no treatment prior to resection of stage II–IV HNSCC |
|
| ||||
| IL-2 | 2 (NCT00006033) | Completed (N = 80) | Multicenter open-label | To compare IL-2 gene with methotrexate in the treatment of recurrent or refractory stage III/IV HNSCC |
| 3 (NCT00002702) | Recruiting (N ~ 260) | Multicenter randomized, controlled trial | To compare surgery and RT with and without rIL-2 in patients with SCC of the mouth or oropharynx | |
|
| ||||
| IL-12 | 1/2 (NCT00004070) | Active, not recruiting (N ~ 28–34) | Multicenter rising-dose study | Patients with unresectable, recurrent, or refractory HNSCC receive IL-12 gene twice during week 1 and once weekly during weeks 2–7 |
|
| ||||
| ALT-801 (a recombinant fusion protein with an IL-2 component) | 1 (NCT00496860) | Recruiting (N ~ 46) | Multicenter dose-escalation study | To determine the MTD of ALT-801 in previously treated patients with progressive metastatic malignancies, including HNC |
|
| ||||
| IRX-2 | 2 (NCT00210470) | Closed (N = 27) | Multicenter open-label trial | Study of IRX-2 with cyclophosphamide, indomethacin, and zinc in patients with newly diagnosed, resectable stage II–IV HNSCC. The study is being conducted to confirm the safety and biological effect of the IRX-2 regimen in the same population to be studied in a planned randomized phase 3 trial. The primary focus will be on observations made from the start of treatment through the planned surgical resection of the primary tumor. |
HNC: head and neck cancer; HNSCC: head and neck squamous cell carcinoma; IFN: interferon; IL: interleukin; MTD: maximum tolerated dose; RT: radiotherapy.