Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host
Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host
University Health Network, Toronto
120 participants
Dec 1, 2015
OBSERVATIONAL
Conditions
Summary
By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options
Eligibility
Inclusion Criteria18
- Age \> 18 years.
- 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
- Disease amenable to biopsy or surgery for tissue procurement
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Willingness and ability of patient to provide signed voluntary informed consent.
Exclusion Criteria4
- Clinically significant hepatic, renal, cardiac or other organ dysfunction likely to limit participation in clinical trials.
- Known brain metastasis
- Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment.
- Any contraindication to undergoing a biopsy procedure.
Interventions
Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02732860