NCT03134027

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

April 25, 2017

Last Update Submit

July 16, 2024

Conditions

Genito Urinary CancerBladder CancerKidney CancerProstate Cancer

Outcome Measures

Primary Outcomes (1)

  • Reconstitution of a matched human immune system in patient derived xenografts (PDXs)

    Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.

    approximately 4 months

Study Arms (2)

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 without an existing PDX

Subjects with prostate cancer amenable to a tumor biopsy.

Procedure: Tumor biopsy

Interventions

Bone marrow biopsyPROCEDURE

Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.

Subjects from which PDXs have been generated.
Tumor biopsyPROCEDURE

Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.

Subjects without an existing PDX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Duke Cancer Institute Patients

You may qualify if:

  • Patients with Genitourinary (GU) Cancers and presence of existing patient derived xenograft or planned collection of tumor for PDX generation
  • Age ≥ 18 years.
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
  • Ability to undergo bone marrow biopsy
  • Laboratory requirements (Hematocrit 30%, Platelets 75,000 + 10\^6/l and WBC 4000 X 10\^6/l)
  • Karnofsky performance status \>70%

You may not qualify if:

  • \. Participants with serious concurrent chronic or acute illness that would affect the safety of a bone marrow biopsy.
  • Patients with prostate cancer
  • a. Biopsies in this study for diseases other than prostate cancer are not permitted.
  • Age ≥ 18 years.
  • Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
  • 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
  • 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.
  • For clinical purpose biopsies: There are no location or risk requirements.
  • Laboratory requirements (Hematocrit 30%, Platelets 75,000 X 10\^6/l and WBC 4000 X 10\^6/l)
  • Karnofsky performance status \>70%
  • \. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Urogenital NeoplasmsUrinary Bladder NeoplasmsKidney NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesKidney DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic Diseases

Study Officials

  • Andrew Armstrong, MD, ScM

    Duke Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

April 28, 2017

Study Start

October 19, 2017

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

US(1)