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

Phase 1

• Conditions: melanoma

• Registration Number: JPRN-UMIN000000822
• Lead Sponsor: Department of Dermatology, Shinshu University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-07
• Study Completion: 2011-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DLT (Dose Limiting Toxicity) AE (Adverse Event) Local antitumor effects

Secondary Outcome Measures

Name	Time	Method
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)