Status:
TERMINATED
A Novel Treatment for Metastatic Melanoma
Lead Sponsor:
Northwestern University
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00758797
Start Date
April 1 2008
End Date
October 1 2012
Last Update
December 3 2021
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611