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

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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

Tracking Information
First Submitted Date April 25, 2017
First Posted Date April 28, 2017
Last Update Posted Date December 21, 2020
Actual Study Start Date October 19, 2017
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 25, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Duke Cancer Institute Patients
Condition
  • Genito Urinary Cancer
  • Bladder Cancer
  • Kidney Cancer
  • Prostate Cancer
Intervention
  • Procedure: Bone marrow biopsy
    Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
  • Procedure: Tumor biopsy
    Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
Study Groups/Cohorts
  • Subjects from which PDXs have been generated.
    Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
    Intervention: Procedure: Bone marrow biopsy
  • Subjects without an existing PDX
    Subjects with prostate cancer amenable to a tumor biopsy.
    Intervention: Procedure: Tumor biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: December 17, 2020)
30
Original Estimated Enrollment
 (submitted: April 25, 2017)
5
Estimated Study Completion Date November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03134027
Other Study ID Numbers Pro00082398
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Andrew Armstrong, MD, ScM Duke Cancer Institute
PRS Account Duke University
Verification Date December 2020