Bladder Cancer, Genito Urinary Cancer, Kidney Cancer, Prostate Cancer
Conditions
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.
Interventions
PROCEDUREBone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
PROCEDURETumor biopsy
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed