A Novel Treatment for Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:

In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758797
• Other study ID #: STU1213
• Status: Terminated
• Phase: Phase 1
• Start date: April 2008
• Est. completion date: October 2012

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.		24 weeks
Secondary	Assess time to disease progression		24 weeks to years
Secondary	Evaluate tumor response by measuring clinically apparent tumors throughout study.		24 weeks
Secondary	Quantify overall survival in this study population		years