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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01800812
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : February 28, 2013
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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 Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
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 : March 2007
Actual Primary Completion Date : January 2008

Primary Outcome Measures :
  1. The occurrence of any adverse event [ Time Frame: up to 8 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT01800812     History of Changes
Other Study ID Numbers: BARDOU PHRC R 2002
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: February 2013