Clinical trial NCT03134027: Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
Official title: Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Genito Urinary Cancer
Bladder Cancer
Kidney Cancer
Prostate Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Duke Cancer Institute Patients

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.


Eligibility 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.

Primary outcomes:
measure: Reconstitution of a matched human immune system in patient derived xenografts (PDXs)
timeFrame: approximately 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Andrew Armstrong, MD, ScM
role: PRINCIPAL_INVESTIGATOR
References: