A Novel Treatment for Metastatic Melanoma

Study Overview
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Brief Summary
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A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.

Detailed Description
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A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser.

Official Title
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In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Other: Photoimmunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site. Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST). Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment): Platelet count > 40,000 per mm3 Absolute Neutrophil Count (ANC) > 1,500 per mm3 Exclusion Criteria: Life expectancy, in the opinion of the investigator of less than 4 months Known allergy to any drugs used in treatment Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment Chemotherapy/immunotherapy within 4 weeks of initiation Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation Radiation therapy at the treatment site within 4 weeks of initiation Uncontrolled brain metastases History of cutaneous photosensitization or photodermatoses Non-treated, active cancers other than melanoma and non-melanoma skin cancers. Active infectious disease requiring antibiotic therapy Unstable medical illness Past or present major psychiatric illness Pregnant or lactating women End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance <50cc/min Acute hepatitis (any cause)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream | Other: Photoimmunotherapy<br>* DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess time to disease progression |  | 24 weeks to years | 
| Evaluate tumor response by measuring clinically apparent tumors throughout study. |  | 24 weeks | 
| Quantify overall survival in this study population |  | years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic melanoma