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

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


  • Org Study ID: Pro00082398
  • Secondary ID:
  • NCT ID: NCT03134027
  • NCT Alias:
  • Sponsor: Duke University - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting October 19, 2017 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Reconstitution of a matched human immune system in patient derived xenografts (PDXs)

Primary Outcome 1 - Time Frame: approximately 4 months

Condition:

  • Genito Urinary Cancer
  • Bladder Cancer
  • Kidney Cancer
  • Prostate Cancer

Eligibility

Criteria:
Inclusion Criteria:

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)

Exclusion Criteria:

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

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Shiaowen David Hsu, MD, PhD

Role: Principal Investigator

Affiliation: Duke Cancer Institute

Overall Contact

Name: Julia Rasmussen, MS, RN, BSN

Phone: 919-681-1030

Email: julia.rasmussen@duke.edu

Location

Facility Status Contact
Duke University Medical Center
Durham, North Carolina 27710
United States
Recruiting Julia Rasmussen, MS, RN, BSN
919-681-1030
julia.rasmussen@duke.edu