ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01800812
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : February 28, 2013
Sponsor:
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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov 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