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Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432 (OK432)

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ClinicalTrials.gov Identifier: NCT01699347
Recruitment Status : Unknown
Verified November 2013 by Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center

Study Description
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Brief Summary:

Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.


Condition or disease Intervention/treatment Phase
CYSTIC MALFORMATION Drug: Intracystic injection of OK432 under US guiding Phase 4

Detailed Description:

A cohort study, before the injection all the patients in the study will go through:

  1. CT/MRI
  2. US to estimate the cyst size
  3. CBC, PT, PTT, INR, ASLO
  4. ECG If the patient is qualified to the study the parent will sign on the inform consent, than the child will be photographed AP and lateral.

The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the cyst contents will be sucked than the OK432 will be injected in.

After the injection the child will stay for one night if it was general anesthesia and 4 hours in the case of local anesthesia.

Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US, stills photo.

Long term follow-up: 6 months, 1 year, 2 years

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
Study Start Date : September 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: OK432
Intracystic injection of OK432 under US guiding
 Drug: Intracystic injection of OK432 under US guiding
Intracystic injection of OK432 under US guiding
Other Name: OK432 (Picibanil)


Outcome Measures
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Primary Outcome Measures :
  1. evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. TREATMENT SAFETY BY no. of participants with adverse events [ Time Frame: 4 YEARS ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
  • ONLY IN THE HEAD AND NECK AREA
  • TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion Criteria:

  • penicillin allergy
  • pregnancy
  • familial history of RF
  • Post streptococcal glomerulonephritis
  • Background illness-heart, kidney, lungs
  • fever > 38.5c in the op day
  • URT Infection
  • Family history of PANDAS
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699347


Locations
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Israel
Department of Otolaryngology, Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Raanan Cohen-Kerem, MD    +97248250279    raanan@clalit.org.il   
Principal Investigator: Raanan Cohen-Kerem, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Raanan Cohen-Kerem, MD Carmel Medical Center, Haifa, Israel
More Information
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Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01699347    
Other Study ID Numbers: CMC-11-0059-CTIL
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013
Keywords provided by Carmel Medical Center:
OK432, CYSTIC MALFORMATION
Additional relevant MeSH terms:
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Congenital Abnormalities
Picibanil
Antineoplastic Agents