- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134027
Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers (Immune PDX)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for Bone Marrow Biopsy:
- 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%
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
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%
Exclusion Criteria for Tumor Biopsy:
1. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Subjects from which PDXs have been generated.
Subjects will be identified from which PDXs have been generated from an already approved IRB protocol.
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Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
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Subjects without an existing PDX
Subjects with prostate cancer amenable to a tumor biopsy.
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Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reconstitution of a matched human immune system in patient derived xenografts (PDXs)
Time Frame: approximately 4 months
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Number of samples yielding a matched human immune system in immunodeficient mice resulting in a PDX with a humanized immune system.
|
approximately 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Armstrong, MD, ScM, Duke Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00082398
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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