Immunotherapy of Head and Neck Cancer: Current and Future Considerations
Table 1
Systemic cell-mediated immunotherapies in clinical development in head and neck cancer [40].
Agent
Phase
Status
Study Type
Description
IFN-
2 (NCT00004897)
Active, not recruiting( 15–45)
Open-label trial
Patients with stage I–III esophageal cancer receive combination chemotherapy and recombinant IFN- followed by surgery and/or RT
3 (NCT00054561)
Completed ()
Multicenter randomized controlled trial
To compare the combination of isotretinoin, recombinant IFN-, and vitamin E with observation only in patients with stage III or IV HNSCC
Pegylated IFN-2b
2 (NCT00276523)
Completed ()
Randomized controlled trial
Pegylated IFN-2b at 3 different dose levels is compared with no treatment prior to resection of stage II–IV HNSCC
IL-2
2 (NCT00006033)
Completed ()
Multicenter open-label
To compare IL-2 gene with methotrexate in the treatment of recurrent or refractory stage III/IV HNSCC
3 (NCT00002702)
Recruiting ()
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 ( 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 ()
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 ()
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.
