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

Duke University

Status: Terminated

Conditions: Genito Urinary Cancer; Bladder Cancer; Kidney Cancer; Prostate Cancer

Treatments: Procedure: Bone marrow biopsy; Procedure: Tumor biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03134027

Pro00082398

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

3 participants in 2 patient groups

Subjects from which PDXs have been generated.

Description:

Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.

Treatment:

Procedure: Bone marrow biopsy

Subjects without an existing PDX

Description:

Subjects with prostate cancer amenable to a tumor biopsy.

Treatment:

Procedure: Tumor biopsy