Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers (Immune PDX)
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|ClinicalTrials.gov Identifier: NCT03134027|
Recruitment Status : Suspended (Suspended due to COVID-19.)
First Posted : April 28, 2017
Last Update Posted : December 21, 2020
The objective of this study is to obtain human blood CD34+ hematopoietic stem/progenitor cells (HSPCs) to reconstitute a match human immune system in our PDX model. The hypothesis is that by using matched leukocytes and PDX from the same patient, rejection of the PDX by the host immune system will not be observed and therefore a preclinical model to study immunotherapy can be developed to study, understand and improve upon our current therapies. HSPCs will be collected from bone marrow aspirate obtained from a bone marrow biopsy.
The secondary objective is to use patient tumor biopsy samples or circulating tumor cell samples to develop additional preclinical models of GU cancers, particularly prostate cancer, that are clinically relevant by generating additional PDXs.
|Condition or disease||Intervention/treatment|
|Genito Urinary Cancer Bladder Cancer Kidney Cancer Prostate Cancer||Procedure: Bone marrow biopsy Procedure: Tumor biopsy|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Subjects from which PDXs have been generated.
Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
Procedure: Bone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
Subjects without an existing PDX
Subjects with prostate cancer amenable to a tumor biopsy.
Procedure: Tumor biopsy
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
- Reconstitution of a matched human immune system in patient derived xenografts (PDXs) [ Time Frame: approximately 4 months ]Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134027
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew Armstrong, MD, ScM||Duke Cancer Institute|