Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
- Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared
laser therapy with or without indocyanine green in patients with stage III or IV
melanoma and cutaneous metastases.
- Determine the complete systemic and local response rates in patients treated with this
- Determine the effect of this treatment on immunologic parameters in these patients.
OUTLINE: This is a prospective, open-label, pilot study.
Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily
on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and
28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples
are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by
flow cytometry), and antibody response (by western blot).
After completion of study treatment, patients are followed monthly for 3 months and then
every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Toxicity and tolerability by CTCAE version 3.0
Mark Naylor, MD
Oklahoma Health Sciences Center - Tulsa
United States: Federal Government
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|