Effects of OM-174 in Adult Patients With Solid Tumors (OM-174)

February 26, 2013 updated by: Centre Hospitalier Universitaire Dijon

Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.

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.

Study Overview

Status

Completed

Conditions

Solid Tumors

Intervention / Treatment

Biological: Injections of OM-174

Study Type

Interventional

Enrollment

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Non-Randomized
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The occurrence of any adverse event Time Frame: up to 8 weeks	up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Isambert N, Fumoleau P, Paul C, Ferrand C, Zanetta S, Bauer J, Ragot K, Lizard G, Jeannin JF, Bardou M. Phase I study of OM-174, a lipid A analogue, with assessment of immunological response, in patients with refractory solid tumors. BMC Cancer. 2013 Apr 2;13:172. doi: 10.1186/1471-2407-13-172.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 22, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)