Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 27, 2007
Last updated: September 19, 2013
Last verified: November 2008

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 Intervention Phase
Melanoma (Skin)
Metastatic Cancer
Drug: imiquimod
Drug: indocyanine green solution
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Toxicity and tolerability by CTCAE version 3.0 [ Designated as safety issue: Yes ]
  • Complete systemic and local response rates at 16 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunologic parameters [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2006
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00453050

United States, Oklahoma
Oklahoma University Cancer Institute
Tulsa, Oklahoma, United States, 74135-2512
Sponsors and Collaborators
Oklahoma Health Sciences Center - Tulsa
Study Chair: Mark Naylor, MD Oklahoma Health Sciences Center - Tulsa
  More Information

Additional Information:
No publications provided Identifier: NCT00453050     History of Changes
Other Study ID Numbers: CDR0000536471, OU-12576, OU-ISPI
Study First Received: March 27, 2007
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas processed this record on March 01, 2015