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)

Brief Summary:

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

Detailed Description:



  • 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)
Primary Purpose: Treatment
Official Title: Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
Study Start Date : March 2006
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Imiquimod

Primary Outcome Measures :
  1. Toxicity and tolerability by CTCAE version 3.0
  2. Complete systemic and local response rates at 16 months

Secondary Outcome Measures :
  1. Immunologic parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00453050

United States, Oklahoma
Oklahoma University Cancer Institute
Tulsa, Oklahoma, United States, 74135-2512
Sponsors and Collaborators
University of Oklahoma
Study Chair: Mark Naylor, MD University of Oklahoma

Publications: Identifier: NCT00453050     History of Changes
Other Study ID Numbers: CDR0000536471
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: November 2008

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
skin metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers