Combined modality treatment for patients with stage IV melanoma: Cyclophosphamide and a dendritic cell vaccine loaded with killed allogeneic melanoma cells

Combined modality treatment for patients with stage IV melanoma: Cyclophosphamide and a dendritic cell vaccine loaded with killed allogeneic melanoma cells - Combination of cyclophosphamide and a dendritic cell vaccine for stage IV melanoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004617

Enrollment

Registered

2011-01-01

Start date

2011-07-01

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

melanoma

Interventions

Administer monocyte-derived dendritic cells subcutaneously every 2 weeks for 4 doses and then every 4 weeks for 3 doses. Administer low dose cyclophosphamide before administering dendritic cells.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biopsy-proven metastatic melanoma 2. PS (ECOG) 0 or 1 3. No active CNS metastatic disease 4. Patients have not received chemotherapy, IFN-alpha, high dose IL-2, corticosteroid or other immunosuppressive agents 5. adequate bone marrow, hepatic, and renal functions 6. Informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1. Patients with a history of neoplasitic disease other than melanoma within 5 years 2. Patients with a history of autoimmune disease 3. Patients with unstable angina pectoris, congestive heart failure, asthma or active systemic infection 4. Positive for HBs Ag, HCV Ab, HTLV-I Ab, HIV Ab, or serological test for syphilis

Design outcomes

Primary

Measure	Time frame
Toxicity of NCI-CTC grade 3 or 4, response rate	—

Secondary

Measure	Time frame
Pass rate of release tests for dendritic cell vaccine, completion rate of dendritic cell vaccine	—

Countries

Japan

Contacts

Public ContactNorimitsu Kadowaki

Kyoto University Hospital Department of Hematology and Oncology

kadowaki@kuhp.kyoto-u.ac.jp075-751-3155

Outcome results

None listed

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