NCT03134027

Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Genito Urinary Cancer
• Bladder Cancer
• Kidney Cancer
• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Bone marrow biopsy	Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
PROCEDURE	Tumor biopsy	Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.

Timeline

• Start date: 2017-10-19
• Primary completion: 2018-05-09
• Completion: 2018-05-09
• First posted: 2017-04-28
• Last updated: 2024-07-18

Locations

1 site across 1 country: United States