Imiquimod and Laser Therapy With or Without a Green Dye in Treating Patients With Stage III or Stage IV Melanoma That Has Spread to Other Parts of the Skin
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. Laser therapy uses light to kill tumor cells. Giving imiquimod together with laser therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of imiquimod and laser therapy with or without a green dye in treating patients with stage III or stage IV melanoma that has spread to other parts of the skin.
Drug: indocyanine green solution
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study|
- Toxicity and tolerability by CTCAE version 3.0
- Complete systemic and local response rates at 16 months
- Immunologic parameters
|Study Start Date:||March 2006|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
- 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 regimen.
- 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 toxicity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453050
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Tulsa, Oklahoma, United States, 74135-2512|
|Study Chair:||Mark Naylor, MD||University of Oklahoma|