A phase I/IIa study of heat immunotherapy using anti-melanoma antibody conjugated magnetoliposome for advanced melanoma patients

UMIN ID: UMIN000000822

Registered date:07/09/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: melanoma
• Date of first enrollment: 2007/10/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Inject an appropriate amount of MML into cutaneous or subcutaneous matastatic lesions locally, and put an alternative magnetic field on them to keep at the temperature of 43-46 degree for 30 min.

Outcome(s)

• Primary Outcome: DLT (Dose Limiting Toxicity) AE (Adverse Event) Local antitumor effects
• Secondary Outcome: Systemic antitumor effects 1. antitumor effect on non-heated lesions 2. level of tumor markers in the patients' sera 3. PFS (Progression Free Survival) 4. OS (Overall Survival)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. An anti-cancer therapy has been received within previous 4 weeks 2. Patients who have brain metastases 3. Patients who have a life expectancy of less than 6 months 4. Patients who are pregnant or nursing 5. Patients who have severe pleural or pericardial effusion or ascites 6. Patients who have active infection 7. Patients who have other malignancies 8. Patients who are unable to keep protocol due to psychiatric, familial, social or traffic disadvantage 9. Patients who have metals inside the body near (within 10 cm) the lesion where alternative magnetic field is put 10. Patients who have active asthma, or have had severe anaphylaxis before. 11. Patients who are judged inappropriate to be enrolled in this study by the doctor in charge

Related Information

• Primary Sponsor: Department of Dermatology, Shinshu University School of Medicine
• Source(s) of Monetary Support: Cancer Translational Research Project