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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injections of OM-174

Biological

Primary outcomes

The occurrence of any adverse event

Time frame: up to 8 weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: OM-174

Important dates

Study start: 2007
Primary completion: 2008
First posted: Feb 28, 2013
Registry last updated: Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed