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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134027
Recruitment Status : Suspended (Suspended due to COVID-19.)
First Posted : April 28, 2017
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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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.


Condition or disease Intervention/treatment
Genito Urinary Cancer Bladder Cancer Kidney Cancer Prostate Cancer Procedure: Bone marrow biopsy Procedure: Tumor biopsy

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Subjects from which PDXs have been generated.
Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
 Procedure: Bone marrow biopsy
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
Subjects without an existing PDX
Subjects with prostate cancer amenable to a tumor biopsy.
 Procedure: Tumor biopsy
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.


Outcome Measures
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Primary Outcome Measures :
  1. Reconstitution of a matched human immune system in patient derived xenografts (PDXs) [ Time Frame: approximately 4 months ]
    Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Duke Cancer Institute Patients
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134027


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Andrew Armstrong, MD, ScM Duke Cancer Institute
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03134027    
Other Study ID Numbers: Pro00082398
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Urologic Neoplasms
Urologic Diseases
Kidney Diseases