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

Terminated

• Conditions: Kidney Cancer; Prostate Cancer; Genito Urinary Cancer; Bladder Cancer
• Interventions: Procedure: Bone marrow biopsy; Procedure: Tumor biopsy

• Registration Number: NCT03134027
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Study Start: 2017-10-19
• Primary Completion: 2018-05-09
• Study Completion: 2018-05-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects from which PDXs have been generated.	Bone marrow biopsy	Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
Subjects without an existing PDX	Tumor biopsy	Subjects with prostate cancer amenable to a tumor biopsy.

Primary Outcome Measures

Name	Time	Method
Reconstitution of a matched human immune system in patient derived xenografts (PDXs)	approximately 4 months	Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States