Effects of OM-174 in Adult Patients With Solid Tumors

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Biological: Injections of OM-174

Study type: Interventional

Funder types: Other

Identifiers

NCT01800812

BARDOU PHRC R 2002

Details and patient eligibility

About

Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed.
• At least one month since the last chemotherapy
• Life expectancy above 3 months
• Written informed consent
• Age above 18

Exclusion criteria

• Patient's refusal
• Infection
• Brain metastasis
• Autoimmune disease
• Regular use of steroids
• Patient included in another protocol
• Chemotherapy or radiotherapy less than 6 weeks ago
• Immunotherapy less than 8 weeks ago