Immunotherapy of Head and Neck Cancer: Current and Future Considerations
Table 3
Vaccines in clinical development in head and neck cancer [40].
Agent
Phase
Status
Study Type
Description
ALVAC-CEA vaccine
2 (NCT00003125)
Active, not recruiting ()
Partially randomized pilot study
For patients with CEA-expressing advanced tumors, including HNC. In stage I, patients receive vaccinia-CEA vaccine and then ALVAC-CEA (CEA-avipox) vaccine, or the reverse sequence. In stage 2, patients receive whichever vaccine was superior, plus GM-CSF IL-2.
Anti-CEA RNA-pulsed DC vaccine
1 (NCT00004604)
Active, not recruiting ()
Dose-escalation study
To determine the MTD of the vaccine in patients who have refractory metastatic cancer, including HNC, that expresses CEA
EBV LMP-2 peptide vaccine
1 (NCT00078494)
Completed ()
Randomized study
Patients with nasopharyngeal cancer that has been controlled with standard therapy receive 1 of 2 LMP-2 vaccines to determine which better prevents cancer recurrence. LMP-2 is a protein produced by EBV.
HPV-16 E7/E6 peptide vaccine
1 (NCT00019110)
Completed ( 40–46)
Multicenter open-label study
Patients with advanced or recurrent cancers, including HNC, receive a vaccine that contains the HPV-16 E7 and E6 peptides
JAX-594 (thymidine kinase-deleted vaccinia virus plus GM-CSF)
1 (NCT00625456)
Recruiting ()
Dose-escalation study
To find the MTD of JAX 594 in patients with refractory solid tumors, including HNSCC
MAGE-A3/HPV-16 vaccine
1 (NCT00257738)
Recruiting ()
Dose-escalation study
Patients with HNSCC receive a vaccine comprised of MAGE-A3 and HPV-16 peptides
1 (NCT00704041)
Recruiting ()
Dose-escalation study
To evaluate 4 doses of the MAGE-A3/HPV-16 vaccine in 2 cohorts of HNSCC patients those with MAGE-A3-positive tumors and those with HPV-16-positive tumors
Multiple-peptide vaccine (LY6K, VEGFR1, VEGFR2)
1 (NCT00561275)
Completed ()
Open-label trial
Patients with esophageal cancer receive a vaccine containing multiple peptides and GM-CSF
p53-pulsed DC vaccine
1 (NCT00404339)
Recruiting ()
Randomized safety trial
Patients with HNSCC receive autologous DCs loaded with wild-type p53 peptides, T-helper peptide epitope
Ras peptide vaccine
2 (NCT00019331)
Completed ()
Single-center trial
To compare 3 regimens of vaccine therapy with tumor-specific mutated Ras peptides plus IL-2 or GM-CSF in patients with metastatic solid tumors, including HNC, that potentially express mutant Ras.
Fowlpox-CEA-TRICOM vaccine (fCEA-TRI)
1 (NCT00028496)
Completed ()
Dose-escalation study
To evaluate fCEA-TRI GM-CSF in patients with advanced or metastatic cancer, including HNC.
1 (NCT00021424)
Completed ()
Dose-escalation study
To find the MTD of fCEA-TRI in patients with advanced SCC of the oral cavity or oropharynx or nodal or dermal metastases
1 (NCT00027534)
Completed ( 6–18)
Dose-escalation study
Immunotherapy comprises autologous DCs treated with fCEA-TRI in patients with CEA-expressing advanced or metastatic cancer, including HNC.
CEA: carcinoembryonic antigen; DC: dendritic cell; EBV: Epstein-Barr virus; HNC: head and neck cancer; HNSCC: head and neck squamous cell carcinoma; IL: interleukin; GM-CSF: granulocyte macrophage colony-stimulating factor; HPV: human papillomavirus; LY6K: lymphocyte antigen 6 complex, locus K; MAGE: melanoma antigene gene; MTD: maximum tolerated dose; TRICOM: TRIad of COstimulatory Molecules (aimed at stimulating a cytotoxic T-cell response); VEGFR: vascular endothelial growth factor receptor.
