Cytokine-induced Killer Study for Patients With Stage II Melanoma

• Status: Not yet recruiting
• Trial end date: 2040-08-01
• Target enrollment: 0
• Participant gender: All

Summary

For investigators' current experimental clinical trial, patients are given 4 injections of ipilimumab, given 3 weeks apart x 4 injections with or without cytokine-induced killer therapy. Investigators propose to test this dual therapy in patients with melanoma who have known stage I, metastatic melanoma. Investigators hypothesize that this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, significant prolongation of progression-free, disease-free or overall survival compared to the use of ipilimumab alone

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First People's Hospital of Changzhou
• Treatments: Antibodies, Monoclonal; Ipilimumab

Criteria

Inclusion Criteria:

• Histological diagnosis of melanoma. AJCC Stage IV (any T, any N, M1), metastatic, progressive, refractory, melanoma.

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. Serum albumin ≥3.0 gm/dL.

Exclusion Criteria:

• Age <18-years-old. Active CNS metastases or carcinomatous meningitis. Patients with CNS lesions that have been treated and who have no evidence of progression in the brain on CT/MRI for ≥1 month are eligible. Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.