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

Prostate Cancer Clinical Trial

— Immune PDX  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03134027
• Other study ID #: Pro00082398
• Status: Suspended
• Start date: October 19, 2017
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Bone Marrow Biopsy:

1. Patients with Genitourinary (GU) Cancers and presence of existing patient derived xenograft or planned collection of tumor for PDX generation

2. Age = 18 years.

3. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.

4. Ability to undergo bone marrow biopsy

5. Laboratory requirements (Hematocrit 30%, Platelets 75,000 + 10^6/l and WBC 4000 X 10^6/l)

6. Karnofsky performance status >70%

Exclusion Criteria for Bone Marrow Biopsy:

1. Participants with serious concurrent chronic or acute illness that would affect the safety of a bone marrow biopsy.

Inclusion Criteria for Tumor Biopsy

1. Patients with prostate cancer

a. Biopsies in this study for diseases other than prostate cancer are not permitted.

2. Age = 18 years.

3. Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.

4. Planned or willing to undergo a tumor biopsy. Biopsies may be for research or clinical purposes depending on the treating provider for men with prostate cancer. Biopsies in this study for diseases other than prostate cancer are not permitted

1. For research only biopsies: At least one lymph node or bone metastatic amenable to a minimum risk biopsy in the opinion of the treating physician.

2. For clinical purpose biopsies: There are no location or risk requirements.

5. Laboratory requirements (Hematocrit 30%, Platelets 75,000 X 10^6/l and WBC 4000 X 10^6/l)

6. Karnofsky performance status >70%

Exclusion Criteria for Tumor Biopsy:

1. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.

Related Conditions & MeSH terms

• Bladder Cancer
• Genito Urinary Cancer
• Kidney Cancer
• Kidney Neoplasms
• Prostate Cancer
• Urogenital Neoplasms

Intervention

Procedure:
• Bone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
• Tumor biopsy
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconstitution of a matched human immune system in patient derived xenografts (PDXs)	Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.	approximately 4 months