A Novel Treatment for Metastatic Melanoma

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00758797

Enrollment

Registered

2008-09-25

Start date

2008-04-30

Completion date

2012-10-31

Last updated

2021-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Keywords

metastatic melanoma

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.

Interventions

OTHERPhotoimmunotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.	24 weeks

Secondary

Measure	Time frame
Assess time to disease progression	24 weeks to years
Evaluate tumor response by measuring clinically apparent tumors throughout study.	24 weeks
Quantify overall survival in this study population	years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026