Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Apr 4, 2016

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to personalize cancer treatment for patients with certain types of cancer, including triple negative breast cancer, colorectal cancer, and high-grade serous ovarian cancer. The study involves taking a small sample of the participant's tumor and implanting it into mice. This helps researchers understand how the tumor might respond to different medications. The goal is to find treatments that are specifically effective for the individual patient based on their unique cancer profile, potentially offering them better options for managing their disease.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of one of the specified cancers. They should also be able to provide a tumor sample through a biopsy or surgery. Participants can expect to work closely with the research team and will need to give their consent to join the study. It's important to note that individuals with certain health conditions, such as significant organ dysfunction or known brain metastasis, won’t be able to participate. Overall, this study aims to advance personalized cancer care and improve treatment outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years.
• 2. Patient diagnosis must be categorized as either (I) OR (II) OR (III) OR (IV):
• (I) Histologically confirmed Triple Negative Breast Cancer by Institutional and American Society of Clinical Oncology (ASCO)/Cancer of American Pathologists (CAP) guidelines, either:
• • Stage IV (metastatic) disease that has not been treated with systemic therapy in the metastatic setting or
• • Stage I to III (non-metastatic) with residual mass by clinical exam and/or breast imaging following anthracycline + taxane-containing neoadjuvant chemotherapy
• • OR
• (II) Histologically-confirmed Stage IV colorectal cancer treated with ≤ 1 line of systemic therapy in the metastatic setting, either:
• • Undergoing surgical resection of liver metastases or
• • With metastatic lesions amenable to biopsy
• • OR
• (III) Histologically-confirmed advanced High Grade Serous Ovarian Cancer, either:
• • Recurrent disease with a life expectancy of at least 12 months or
• • Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence
• • OR
• • (IV) Histologically confirmed solid tumor not meeting criteria for (I), (II) or (III) above, for which evaluation of investigational therapies is of particular interest or where clinical need exists, at the discretion of the PI
• • 3. Disease amenable to biopsy or surgery for tissue procurement
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• • 5. Willingness and ability of patient to provide signed voluntary informed consent.
• Exclusion Criteria:
• • 1. Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials.
• • 2. Known brain metastasis
• • 3. Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
• • 4. Any contraindication to undergoing a biopsy procedure.