Testing personalized cancer treatments using patient-derived tumors in mice

Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host

This study is trying to see if using personalized tumor samples from patients with certain types of cancer in mice can help find the best treatments for those patients.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT02732860 on ClinicalTrials.gov

What this trial studies

This study involves obtaining clinical specimens from patients with triple negative breast cancer, colorectal cancer, and high-grade serous ovarian cancer to create personalized patient-derived xenografts (pPDX) in mice. These pPDX models will be used to conduct molecular profiling and drug sensitivity testing to identify effective treatment options tailored to the individual patient. The goal is to enhance clinical decision-making by correlating the drug responses observed in the pPDX with the actual responses of the patients to therapy. This approach aims to bridge the gap between pre-clinical models and clinical management of cancer.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with specific types of advanced cancers such as triple negative breast cancer, stage IV colorectal cancer, or high-grade serous ovarian cancer.

Not a fit: Patients with early-stage cancers or those who do not meet the specific histological criteria for inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with more effective, personalized treatment options based on their unique cancer profiles.

How similar studies have performed: Previous studies using patient-derived xenografts have shown promising results in predicting patient responses to therapy, indicating potential success for this approach.

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.

Where this trial is running

Toronto, Ontario

• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: David Cescon, MD — Princess Margaret Cancer Centre
• Study coordinator: David Cescon, MD

Conditions: Colorectal Neoplasms, Colorectal Cancer, Breast Cancer, Breast Neoplasms, Ovarian Cancer, Ovarian Neoplasm, personalized patient-derived xenografts, molecular profiling