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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||October 19, 2017||Observational|
Primary Outcome 1 - Measure: Reconstitution of a matched human immune system in patient derived xenografts (PDXs)
Primary Outcome 1 - Time Frame: approximately 4 months
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
1. Participants with serious concurrent chronic or acute illness that would affect the
safety of a bone marrow biopsy.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Shiaowen David Hsu, MD, PhD
Role: Principal Investigator
Affiliation: Duke Cancer Institute