Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Treatment	Closed	18 to 100	Other	OU-12576 12576, OU-ISPI, NCT00453050

Objectives

Primary

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.
2. Determine the complete systemic and local response rates in patients treated with this regimen.

Secondary

1. Determine the effect of this treatment on immunologic parameters in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

• 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

Patient Characteristics:

• 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

Expected Enrollment

A total of 70 patients will be accrued for this study.

Outcomes

Toxicity and tolerability by CTCAE version 3.0
Complete systemic and local response rates at 16 months

Immunologic parameters

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.

Trial Contact Information

Trial Lead Organizations

Oklahoma Health Sciences Center - Tulsa

Mark Naylor, MD, Protocol chair		Ph: 918-619-4466

Registry Information
Official Title		Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study
Trial Start Date		2006-03-01
Trial Completion Date		2009-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00453050
Date Submitted to PDQ		2007-02-09
Information Last Verified		2008-11-30

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