Tissue Study of Bv8/PK-2 Inhibition in Human Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01656824
First received: August 1, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. than we will implant primary human tumor tissue (taken from surgical specimens after informed consent)in those mice and follow-up on the mice.


Condition
Cancer

Study Type: Observational
Official Title: Study of Human Primary Cancer Tissue Implanted in Mice Lacking Bv8/PH-2 in Their Bone Marrow-derived Cells

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Tumor growth in xenograft model [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

cancer tissues


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Detailed Description:

1-10 grams of human cancer tissue will be taken from surgical specimen without interference to the pathological data gathering process. those tissues will be implanted in nude mice that will either be treated with anti-Bv8 antibodies or will be transplanted with bone marrow in which Bv8 expression is silenced.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with pancreatic cancer and are candidates for whipple's procedure

Criteria

Inclusion Criteria:

  • ages 18-85 years
  • Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy

Exclusion Criteria:

  • refuse to take part
  • preoperative chemotherapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656824

Contacts
Contact: Erez Hasnis, MD; PhD 972-50-2061911 e_hasnis@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Erez Hasnis, MD;PhD    972-50-2061911    e_hasnis@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Erez Hasnis, MD;PhD Rambam Health Care Campus
Principal Investigator: Erez Hasnis, MD; PhD. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01656824     History of Changes
Other Study ID Numbers: Bv8/PK-2CTIL
Study First Received: August 1, 2012
Last Updated: November 20, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Bv8/PK-2
MDSC Myeloid Derived Suppressor Cells
BMDC Bone Marrow Derived Cells
Angiogenesis
Pancreatic Cancer

ClinicalTrials.gov processed this record on September 30, 2014