Cytokine-induced Killer Study for Patients With Stage II Melanoma

NCT02498756 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Melanoma001
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  5 years

• Progression Free Survival (PFS)

  1 year

Study Arms (2)

IP plus CIK

EXPERIMENTAL

Patients receive ipilimumab and CIK.

Biological: Cytokine-induced killer cells; Drug: Ipilimumab

IP alone

ACTIVE COMPARATOR

Patients receive ipilimumab alone.

Drug: Ipilimumab

Interventions

Cytokine-induced killer cells BIOLOGICAL

CIK cells are transferred every 3 months for 1 year.

IP plus CIK

Ipilimumab DRUG

Ipilimumab are delivered every 3 weeks for one year

IP alone; IP plus CIK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 15, 2015
• Study Start: August 1, 2015
• Primary Completion (Estimated): August 1, 2038
• Study Completion (Estimated): August 1, 2040
• Last Updated: July 15, 2015

Record last verified: 2015-07