A Novel Treatment for Metastatic Melanoma

Stopped early · Phase 1

Conditions studied: Metastatic Melanoma

In brief

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

Key facts

Study ID

NCT00758797

Run by

Northwestern University

People needed

7

Starts

2008-04-01

Expected to finish

2012-10-01

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Northwestern University Feinberg School of Medicine, Department of Dermatology — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.