A Novel Treatment for Metastatic Melanoma

Overview

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

Full Title of Study: “In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2012

Detailed Description

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.

Interventions

  • Other: Photoimmunotherapy
    • DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Arms, Groups and Cohorts

  • Experimental: 1
    • DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Clinical Trial Outcome Measures

Primary Measures

  • Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
    • Time Frame: 24 weeks

Secondary Measures

  • Assess time to disease progression
    • Time Frame: 24 weeks to years
  • Evaluate tumor response by measuring clinically apparent tumors throughout study.
    • Time Frame: 24 weeks
  • Quantify overall survival in this study population
    • Time Frame: years

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18 and older 2. Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site. 3. Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST). 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 5. 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:

1. Life expectancy, in the opinion of the investigator of less than 4 months 2. Known allergy to any drugs used in treatment 3. Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment 4. Chemotherapy/immunotherapy within 4 weeks of initiation 5. Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation 6. Radiation therapy at the treatment site within 4 weeks of initiation 7. Uncontrolled brain metastases 8. History of cutaneous photosensitization or photodermatoses 9. Non-treated, active cancers other than melanoma and non-melanoma skin cancers. 10. Active infectious disease requiring antibiotic therapy 11. Unstable medical illness 12. Past or present major psychiatric illness 13. Pregnant or lactating women 14. End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance <50cc/min 15. Acute hepatitis (any cause)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Murad Alam, Professor in Dermatology, Otolaryngology – Head and Neck Surgery, and Surgery-Organ Transplantation – Northwestern University
  • Overall Official(s)
    • Murad Alam, MD, Principal Investigator, Northwestern University

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