Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04602702
Other study ID # SUN-2047
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2022
Source Sunnybrook Health Sciences Centre
Contact Hon S Leong, PhD
Phone 416-480-6100
Email hon.leong@sri.utoronto.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Canada Odette Cancer Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Complete Response, Partial Response 3-9 months
Primary Stable Disease Response 3-9 months
Primary Progressive Disease Response 3-9 months
See also
  Status Clinical Trial Phase
Completed NCT02248389 - Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses Phase 1
Completed NCT03900364 - a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy N/A
Completed NCT00158782 - Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients Phase 1
Completed NCT03109015 - Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing Phase 2
Completed NCT00363194 - A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients Phase 1
Completed NCT01012011 - Regulatory Post Marketing Surveillance Study on Nexavar® N/A
Completed NCT00842790 - Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging N/A
Completed NCT00529802 - Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer Phase 2
Completed NCT00338884 - Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer Phase 2
Completed NCT00387764 - Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer Phase 3
Completed NCT00356460 - Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma Phase 1
Completed NCT00095186 - Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma Phase 2
Completed NCT00079612 - Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer Phase 2
Completed NCT00043368 - PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909) Phase 2
Active, not recruiting NCT04489771 - A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013) Phase 2
Completed NCT00516672 - Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors Phase 1
Withdrawn NCT05104905 - A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma Phase 1/Phase 2
Terminated NCT03685591 - PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors Phase 1
Withdrawn NCT03111901 - Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer Phase 1/Phase 2
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1