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
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|ClinicalTrials.gov Identifier: NCT00453050|
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : May 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin) Metastatic Cancer||Drug: imiquimod Drug: indocyanine green solution Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Masking:||None (Open Label)|
|Official Title:||Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2009|
- Toxicity and tolerability by CTCAE version 3.0
- Complete systemic and local response rates at 16 months
- Immunologic parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453050
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Tulsa, Oklahoma, United States, 74135-2512|
|Study Chair:||Mark Naylor, MD||University of Oklahoma|