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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    120
  • sponsor
    University Health Network, Toronto
Updated on 30 April 2022
cancer
systemic therapy
breast cancer
residual tumor
anthracyclines
metastasis
liver metastasis
cancer treatment
cancer chemotherapy
recurrent disease
triple negative breast cancer
taxane
stage iv colorectal cancer
cancer of the ovary

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

Description

Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.

Details
Condition Colorectal Neoplasms, Colorectal Cancer, Breast Cancer, Breast Neoplasms, Ovarian Cancer, Ovarian Neoplasm
Treatment Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures
Clinical Study IdentifierNCT02732860
SponsorUniversity Health Network, Toronto
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Stage III or IV with residual disease following neoadjuvant chemotherapy, or at
Recurrent disease with a life expectancy of at least 12 months or
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 Criteria

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
Any contraindication to undergoing a biopsy procedure
consent such as dementia or severe cognitive impairment
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