Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation

Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation - Phase I study for immuno-hyperthermia against recurrent subcutaneous tumor using cationic magnetoliposome and alternative magnetic field irradiation

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002701

Enrollment

Registered

2009-11-04

Start date

2009-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

subcutaneous recurrent tumor (breast cancer, malignant head and neck tumor, malignant soft tissue tumor, malignant oral cavity tumor)

Interventions

cationic magnetoliposome level I: 5mg/body level II: 50mg/body level III: 200mg/body Alternative magnetic field irradiation on the day of injection and the next day Resection of injected tumor on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The case with metastatic measurable tumor in skin or subcutaneous tissue (including lymph node) which is confirmed histologically or cytologically and also the tumor should be larger than the size of designated level. Refractory to the standard medical therapy (chemotherapy, hormonal therapy, etc) and more than 4 weeks should elapse since the latest treatment. The case who underwent radiotherapy more than 4 weeks earlier or without indication for radiotherapy The case with the tumor which can be punctured. The tumor should be located less than 30mm in depth and also amenable to injection. Performance status(ECOG) 0 to 2. White blood cell counts >=2,000/uL or neutrophil counts >=1,000/uL Platelets >=50,000/uL Serum creatinine <=3mg/dl AST(GOT)/ALT(GPT) both <=100 IU/L or <=5 X institutional criterion Having written informed consent.

Exclusion criteria

Exclusion criteria: The case having intracorporal magnetic substance (cardiac pace maker, dental implant, steel clips, steel bolts) Pregnant woman, nursing woman The case having pleural effusion, ascites, pericardial effusion which requires emergent treatment The case having active infection The case having double cancer with less than 5 year-disease free period The case having psychological, familial, social, geographical factors which hamper compliance with the protocol and appropriate follow-up The case having brain metastases which require emergent treatment for brain hypertension or emergent irradiation The case who is considered to be inappropriate for this trial by the attending doctor

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity and other adverse events	—

Countries

Japan

Contacts

Public ContactToyone Kikumori

Nagoya University Hospital Department of Breast and Endocrine Surgery

kikumori@med.nagoya-u.ac.jp052-744-2251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026