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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
David Cescon, MD
Dave.Cescon@uhn.ca
416-946-2245
Time Frame
Start Date: 2015-12
Estimated Completion Date: 2026-01-04
Participants
Target number of participants: 120
Treatments
Triple Negative Breast Cancer
Triple negative breast cancer patients with residual invasive disease following neoadjuvant chemotherapy (n= up to 15) or with newly diagnosed metastatic disease (n=up to 30).~After the screening procedures confirms patient eligibility:~* Molecular Profiling will be performed on clinical sample~* pPDX generation for in vivo drug testing~* In vitro organoid culture generation (if sufficient fresh tissue available)~* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
Colorectal Cancer
Colorectal cancer patients with metastatic disease undergoing resection of liver metastases, or with lesions amenable to biopsy (n=up to 15).~After the screening procedures confirms patient eligibility:~* Molecular Profiling will be performed on clinical sample~* pPDX generation for in vivo drug testing~* In vitro organoid culture generation (if sufficient fresh tissue available)~* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
High Grade Serous Ovarian Cancer
High grade serous ovarian cancer patients with recurrent disease with a life expectancy of at least 12 months (n=up to 15), or Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence (n=up to 15).~After the screening procedures confirms patient eligibility:~* Molecular Profiling will be performed on clinical sample~* pPDX generation for in vivo drug testing~* In vitro organoid culture generation (if sufficient fresh tissue available)~* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
Other tumor types
Other selected tumor types at the discretion of the PI (n= up to 30)~After the screening procedures confirms patient eligibility:~* Molecular Profiling will be performed on clinical sample~* pPDX generation for in vivo drug testing~* In vitro organoid culture generation (if sufficient fresh tissue available)~* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov