A Novel Treatment for Metastatic Melanoma

Northwestern University

Status and phase: Terminated; Phase 1

Conditions: Metastatic Melanoma

Treatments: Other: Photoimmunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00758797

STU1213

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

1

Experimental group

Description:

DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream

Treatment:

Other: Photoimmunotherapy