Clinical trial NCT00758797: A Novel Treatment for Metastatic Melanoma
Official title: In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Melanoma
Keywords: metastatic melanoma
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
timeFrame: 24 weeks
Secondary outcomes:
measure: Assess time to disease progression
timeFrame: 24 weeks to years
measure: Evaluate tumor response by measuring clinically apparent tumors throughout study.
timeFrame: 24 weeks
measure: Quantify overall survival in this study population
timeFrame: years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: