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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453050
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : May 6, 2015
Information provided by:
National Cancer Institute (NCI)

March 27, 2007
March 28, 2007
May 6, 2015
March 2006
March 2009   (Final data collection date for primary outcome measure)
  • Toxicity and tolerability by CTCAE version 3.0
  • Complete systemic and local response rates at 16 months
Same as current
Complete list of historical versions of study NCT00453050 on Archive Site
Immunologic parameters
Same as current
Not Provided
Not Provided
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
Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study

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.



  • 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.

Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Melanoma (Skin)
  • Metastatic Cancer
  • Drug: imiquimod
  • Drug: indocyanine green solution
  • Other: flow cytometry
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
March 2009   (Final data collection date for primary outcome measure)


  • Histologically confirmed melanoma meeting the following criteria:

    • Stage III or IV disease

      • Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed
    • Presence of 1 or more cutaneous metastases ≤ 3 cm in size

      • Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness
  • No uncontrolled brain metastases

    • Treated brain metastases that are stable for 3 months allowed at the investigator's discretion


  • ECOG performance status 0-2
  • Life expectancy ≥ 4 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 month after study completion
  • No known allergy to any drugs used during study treatment
  • No unstable medical illness
  • Not immunosuppressed

    • Patients immunosuppressed due to disease (e.g., HIV positive) allowed


  • No systemic steroids or any other immunosuppressive medications within the past month
  • No chemotherapy within the past 4 weeks
  • No radiotherapy to the treatment site within the past 4 weeks

    • Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed
  • No concurrent immunosuppressive agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Oklahoma
Not Provided
Study Chair: Mark Naylor, MD University of Oklahoma
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP