Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: March 2009

OBJECTIVES:

Primary - 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.

Secondary - 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.

Intervention(s) in this Clinical Trial

• Drug: imiquimod
• Drug: indocyanine green solution
• Procedure: flow cytometry
• Procedure: immunologic technique
• Procedure: laboratory biomarker analysis

Primary Measures

• Toxicity and tolerability by CTCAE version 3.0
  • Safety Issue?: Yes
• Complete systemic and local response rates at 16 months
  • Safety Issue?: No

Secondary Measures

• Immunologic parameters
  • Safety Issue?: No

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

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oklahoma Health Sciences Center - Tulsa

Overall Clinical Trial Officials and Contacts

Mark Naylor, MD Study Chair Oklahoma Health Sciences Center - Tulsa  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00453050

Study ID Number: CDR0000536471

ClinicalTrials.gov Identifier: NCT00453050

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database