Genito Urinary CancerImmune PDXNCT03134027
Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
An observational study of Genito Urinary Cancer and Bladder Cancer, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genito Urinary Cancer, Bladder Cancer, Kidney Cancer
- What is being tested?
- Bone marrow biopsy and Tumor biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 9 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Duke Cancer Institute Patients
Who may be able to join
- 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%
Show all 15Show fewer
- Patients with prostate cancer
- 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%
Who cannot join
- 1. Participants with serious concurrent chronic or acute illness that would affect the safety of a bone marrow biopsy.
- 1. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Genito Urinary Cancer, Bladder Cancer, Kidney Cancer, Prostate Cancer
- Being tested
- Bone marrow biopsy, Tumor biopsy
- Medical subject headings
- Urogenital Neoplasms, Urinary Bladder Neoplasms, Kidney Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow biopsyProcedure or surgery
Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
Tumor biopsyProcedure or surgery
Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
| Study group | Role | What they receive |
|---|---|---|
| Subjects from which PDXs have been generated. | Subjects will be identified from which PDXs have been generated from an already approved IRB protocol. Receives: Procedure: Bone marrow biopsy | |
| Subjects without an existing PDX | Subjects with prostate cancer amenable to a tumor biopsy. Receives: Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start19 Oct 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genito Urinary CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Armstrong, MD, ScM, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134027
- Sponsor's protocol ID
- Pro00082398
- Acronym
- Immune PDX
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2017
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers
- ClinicalTrials.gov ID
- NCT03134027
- Acronym / sponsor ID
- Immune PDX / Pro00082398
- Conditions
- Genito Urinary Cancer, Bladder Cancer, Kidney Cancer, Prostate Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects from which PDXs have been generated. | – | Procedure: Bone marrow biopsySubjects will be identified from which PDXs have been generated from an already approved IRB protocol. |
| Subjects without an existing PDX | – | Procedure: Tumor biopsySubjects with prostate cancer amenable to a tumor biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Duke Cancer Institute Patients
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (2 listed)
- 1. Participants with serious concurrent chronic or acute illness that would affect the safety of a bone marrow biopsy.
- 1. Participants with serious concurrent chronic or acute illness that would affect the safety of a tumor biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow biopsySubjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection. | Procedure or surgery | Subjects from which PDXs have been generated. |
| Tumor biopsySubjects will undergo a tumor biopsy to obtain tissue for generation of a PDX. | Procedure or surgery | Subjects without an existing PDX |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
Related trials for Genito Urinary Cancer
RecruitingPhase 2
Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer
Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer
RecruitingObservational study
Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study
Malignant Digestive System Neoplasm, Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Endocrine Tumors, Non-Small Cell Lung Cancer
RecruitingObservational study
Gender Related Coping and Survivorship for Genitourinary Cancers
Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Armstrong, MD, ScM principal investigator
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genito Urinary Cancer and Bladder Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reconstitution of a matched human immune system in patient derived xenografts (PDXs) (time frame: approximately 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.