Completed
OM-174Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.
What is being tested
Injections of OM-174
Biological
Who is being recruted
Over 18 Years
+13 Eligibility Criteria
How is the trial designed
Phase 1
Interventional
Study Start: March 2007
Summary
Principal SponsorCentre Hospitalier Universitaire Dijon
Last updated: February 28, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2007
Actual date on which the first participant was enrolled.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.
Principal SponsorCentre Hospitalier Universitaire Dijon
Last updated: February 28, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Age above 18
At least one month since the last chemotherapy
Life expectancy above 3 months
Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed
Show More Criteria
8 exclusion criteria prevent from participating
Autoimmune disease
Brain metastasis
Chemotherapy or radiotherapy less than 6 weeks ago
Immunotherapy less than 8 weeks ago
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers