Clinical trial · Interventional
A Novel Treatment for Metastatic Melanoma
In Situ Photoimmunotherapy: A Tumor Directed Treatment for Advanced Melanoma With Cutaneous Metastases
NCT00758797CI-TRIAL-00055362terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was not renewed during annual Northwestern Cancer Center review.
Summary
Brief summary (as posted)
A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoimmunotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream
- interventionNames
- Other: Photoimmunotherapy
Primary outcomes (1)
- measure
- Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events.
- timeFrame
- 24 weeks
Secondary outcomes (3)
- measure
- Assess time to disease progression
- timeFrame
- 24 weeks to years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.