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Hyper-Personalized Medicine Using Patient Derived Xenografts (PDXovo) for Metastatic Solid Tumors (PDXovo)

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ClinicalTrials.gov Identifier: NCT04602702
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Brief Summary:
The Investigators will use novel PDX (patient-derived xenograft) technology to form xenografts using material from metastatic solid tumor patients. Xenografts will be treated with a panel of drugs to determine which agent(s) yield the greatest anti-tumor effect on the xenograft.

Condition or disease
Kidney Neoplasm Carcinoma, Renal Cell Metastatic Solid Tumor

Detailed Description:

The goal is to use PDXovos, which are chick embryos cultivated in an ex ovo fashion that will act as a xenograft host, for drug paneling. Chick embryos as a PDX host model system offer multiple advantages, such as increased tumor take rates, rapid drug testing, a short evaluation timeframe, and an undeveloped adaptive immune system. Collectively, these advantages allow for implantation of tumor xenografts, subsequent growth in vivo, subsequent drug challenge, and subsequent evaluation for anti-tumor effects.

Patients with metastatic forms of solid tumors will be enrolled regardless of subtype. Metastases will be provided either via metastasectomy or needle core biopsy of metastatic deposits. Spinal and intracranial metastases will be included. Thoracentesis and paracentesis fluid samples yielding tumor tissue will also be included.

Tissue will be processed and briefly cultured in vitro. Upon authentication and expansion to a suitable number of cells, xenografts will be formed in the chick embryo pre-clinical model. After implantation (2 days later), drug treatments will be applied topically to each xenograft's surface. Drug treatments are: sunitinib, pazopanib, axitinib, temsirolimus, cabozantinib, gemcitabine (N>18/treatment group).

Evaluation of xenografts for anti-tumor effects will be performed via ultrasound imaging (changes in tumor volume and tumor vascularity) and confirmed by histology (H&E, TUNEL, CD31+ microvessel density). Treatments will be compared to vehicle control (5% DMSO in saline) treated xenografts. ANOVA (2-way, p<0.01, bon ferroni alpha corrected) analysis will be performed to identify treatments that lead to the greatest decrease in tumor volume and tumor vascularity (ultrasound imaging metrics). Agents identified will not be used to intervene in clinical care. Objective response rates with clinically chosen drug in each patient will be compared to the corresponding PDX drug panel results using kappa analysis.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: INVESTIGATING THE POTENTIAL OF SHORT-TERM PATIENT DERIVED XENOGRAFTS FOR PERSONALIZED MEDICINE FOR PATIENTS WITH METASTATIC SOLID TUMORS: A Non-interventional Clinical Trial.
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022



Primary Outcome Measures :
  1. Objective Response [ Time Frame: 3-9 months ]
    Complete Response, Partial Response

  2. Stable Disease Response [ Time Frame: 3-9 months ]
  3. Progressive Disease Response [ Time Frame: 3-9 months ]

Biospecimen Retention:   Samples Without DNA
metastasectomy specimens, needle core biopsies, thoracentesis, paracentesis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic solid tumors identified at Sunnybrook Health Sciences Centre - Odette Cancer Centre
Criteria

Patient eligibility:

Localized solid tumor inclusion criteria:

i) Age 18+ ii) localized solid tumor irrespective of subtype undergoing curative surgery iii) Consent to provide tumor tissue for this research

Metastatic cancer inclusion criteria:

i) Age 18+ ii) metastatic cancer irrespective of subtype undergoing a needle biopsy or resection of lung, liver or brain as part of their routine clinical care.

iii) metastatic cancer irrespective of disease site undergoing a thoracentesis or paracentesis as part of their routine clinical care.

iv) measurable disease as per RECIST 1.1 criteria v) Consent to provide tumor tissue for this research


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): NCT04602702


Contacts
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Contact: Hon S Leong, PhD 416-480-6100 ext 5748 hon.leong@sri.utoronto.ca
Contact: Sue Santillo 416-480-6100 ext 3914 sue.santillo@sunnybrook.ca

Locations
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Canada, Ontario
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Elyse Watkins, BSc, PGDip    416-480-6100 ext 84632    elyse.watkins@sunnybrook.ca   
Contact: Hon S Leong, PhD    416-480-6100 ext 5748    hon.leong@sri.utoronto.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Georg Bjarnason, MD Sunnybrook Hospital/Odette Cancer Centre
Study Director: Elyse Watkins, BSc, PGDip Sunnybrook Hospital/Odette Cancer Centre
Principal Investigator: Nir Lipsman, MD Sunnybrook Hospital
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04602702    
Other Study ID Numbers: SUN-2047
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
hyper-personalized medicine
patient derived xenograft
chick embryo
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases