Effects of OM-174 in Adult Patients With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Blinding Strategy

NONE

Interventions

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Injections of OM-174

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED

PMID: 23547558 (View on PubMed)

Other Identifiers

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BARDOU PHRC R 2002

Identifier Type: -

Identifier Source: org_study_id