Effects of OM-174 in Adult Patients With Solid Tumors

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT01800812

Collaborator

(none)

Enrollment

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Biological: Injections of OM-174	Phase 1

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

The occurrence of any adverse event [up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT01800812

Other Study ID Numbers:

BARDOU PHRC R 2002

First Posted:

Feb 28, 2013

Last Update Posted:

Feb 28, 2013

Last Verified:

Feb 1, 2013

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Feb 28, 2013