A Novel Treatment for Metastatic Melanoma
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 04/30/2014 |
| Pirmasis pateikimas: | 06/22/2008 |
| Numatytas registravimas pateiktas: | 09/23/2008 |
| Pirmas paskelbtas: | 09/24/2008 |
| Paskutinis atnaujinimas pateiktas: | 05/21/2014 |
| Paskutinis atnaujinimas paskelbtas: | 05/22/2014 |
| Faktinė studijų pradžios data: | 03/31/2008 |
| Numatoma pirminio užbaigimo data: | 09/30/2012 |
| Numatoma studijų užbaigimo data: | 09/30/2012 |
Būklė ar liga
Intervencija / gydymas
Other: 1
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: 1 DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream | Other: 1 DIOMED laser + photosensitizing agent injected intralesionally and topical immuno-modulating cream |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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) |
Rezultatas
Pirminės rezultatų priemonės
1. Tolerability, safety, toxicity, of novel treatment through evaluation of subject response and physician observation of adverse events. [24 weeks]
Antrinės rezultatų priemonės
1. Assess time to disease progression [24 weeks to years]
2. Evaluate tumor response by measuring clinically apparent tumors throughout study. [24 weeks]
3. Quantify overall survival in this study population [years]
