Renal Cell CarcinomaWindMIL-001NCT04341740
Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma
A study testing Bone Marrow Aspirate in people with Renal Cell Carcinoma and Urothelial Carcinoma, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this research is to collect health-related information as well as bone marrow and blood specimens to determine if a new form of treatment for patients with kidney and bladder cancer may be possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Urothelial Carcinoma
- What is being tested?
- Bone Marrow Aspirate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 9 Apr 2021
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years
- Histologically-confirmed, locally advanced unresectable or metastatic RCC (cohort A) or UC (cohort B).
- ECOG performance status of ≤1
- Adequate bone marrow function:
- Platelet count ≥ 100 × 10^9/L
- ANC ≥ 1.0 ×10^9/L
- Lymphocyte count ≥ 0.5 ×10^9/L
- Willingness to undergo bone marrow aspiration (BMA)
Who cannot join
- Prior hematopoietic stem cell transplantation
- Prior radiation to the pelvic region
- Use of systemic corticosteroids within 28 days of BMA
- History of another primary malignancy that has been diagnosed or required therapy within the past 2 years (except completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site).
- Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. If the autoimmune disease has been treated, it must be stable clinically. (Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is not considered an exclusion criterion.)
- Pregnant females as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 21 days of BMA
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- Infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of BMA
- Known diagnosis of HIV or CMV infection or active viral hepatitis
- Administration of hematopoietic growth factor support within 14 days before bone marrow aspiration
- Chemotherapy administration within 28 days of BMA
- Unwilling or unable to comply with the protocol
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma
The purpose of this research is to collect health-related information as well as bone marrow and blood specimens to determine if a new form of treatment for patients with kidney and bladder cancer may be possible.
Read the detailed description
This research will collect specimens from the bone marrow and blood to determine if a new treatment for kidney or bladder cancer may be possible. This research study will collect a bone marrow sample as well as a blood sample.
Participation in the research study will last approximately 60 days which includes time to determine if the patient is eligible to participate in the study, perform the research procedures and follow-up with the patient following the research procedures to determine if they are experiencing any side effects. Participation will end approximately 30 days following the bone marrow collection.
The bone marrow and blood samples will be collected from all patients in both cohorts only at a single time point, after they have been enrolled on the study.
- Conditions
- Renal Cell Carcinoma, Urothelial Carcinoma
- Being tested
- Bone Marrow Aspirate
- Keywords
- marrow infiltrating lymphocytes
- Medical subject headings
- Carcinoma, Renal Cell, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow AspirateProcedure or surgery
bone marrow aspiration
| Study group | Role | What they receive |
|---|---|---|
| Renal Cell Carcinoma or Urothelial Carcinoma Patients | Experimental | Patients in both cohorts (RCC or UC) will undergo bone marrow aspiration under conscious sedation to withdraw 60 mL bone marrow aspirate and 75 ml of peripheral blood sample. Receives: Procedure: Bone Marrow Aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with successful isolation and ex-vivo expansion of MILs
A successful expansion will be greater than or equal to 50% viable and greater than or equal to 50% CD3 positive.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start22 Jul 2020
- Primary completion9 Mar 2021
- Study completion9 Apr 2021
Why it stopped: Study funding was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients enrolled on this study in either the Renal Cell Carcinoma cohort or the Urothelial Carcinoma cohort will undergo the same procedures of bone marrow aspiration and blood draw.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- WindMIL Therapeutics
- Responsible party
- Sponsor
- Investigators
- Abhishek Tripathi, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341740
- Sponsor's protocol ID
- OI-SCC-WINDMIL-001
- Acronym
- WindMIL-001
- Status last verified
- Dec 2023
- First submitted
- 7 Apr 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04341740
- Acronym / sponsor ID
- WindMIL-001 / OI-SCC-WINDMIL-001
- Conditions
- Renal Cell Carcinoma, Urothelial Carcinoma
- Keywords
- marrow infiltrating lymphocytes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study funding was withdrawn.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- WindMIL Therapeutics
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 10 Apr 2020 (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 purpose of this research is to collect health-related information as well as bone marrow and blood specimens to determine if a new form of treatment for patients with kidney and bladder cancer may be possible.
Detailed description
This research will collect specimens from the bone marrow and blood to determine if a new treatment for kidney or bladder cancer may be possible. This research study will collect a bone marrow sample as well as a blood sample.
Participation in the research study will last approximately 60 days which includes time to determine if the patient is eligible to participate in the study, perform the research procedures and follow-up with the patient following the research procedures to determine if they are experiencing any side effects. Participation will end approximately 30 days following the bone marrow collection.
The bone marrow and blood samples will be collected from all patients in both cohorts only at a single time point, after they have been enrolled on the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients enrolled on this study in either the Renal Cell Carcinoma cohort or the Urothelial Carcinoma cohort will undergo the same procedures of bone marrow aspiration and blood draw.
| Arm | Type | Receives |
|---|---|---|
| Renal Cell Carcinoma or Urothelial Carcinoma Patients | Experimental | Procedure: Bone Marrow AspiratePatients in both cohorts (RCC or UC) will undergo bone marrow aspiration under conscious sedation to withdraw 60 mL bone marrow aspirate and 75 ml of peripheral blood sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Histologically-confirmed, locally advanced unresectable or metastatic RCC (cohort A) or UC (cohort B).
- ECOG performance status of ≤1
- Adequate bone marrow function:
- Willingness to undergo bone marrow aspiration (BMA)
Key exclusion criteria (12 listed)
- Prior hematopoietic stem cell transplantation
- Prior radiation to the pelvic region
- Use of systemic corticosteroids within 28 days of BMA
- History of another primary malignancy that has been diagnosed or required therapy within the past 2 years (except completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site).
- Presence of an autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring active systemic treatment. If the autoimmune disease has been treated, it must be stable clinically. (Hypothyroidism without evidence of Grave's disease or Hashimoto's thyroiditis is not considered an exclusion criterion.)
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 Aspiratebone marrow aspiration | Procedure or surgery | Renal Cell Carcinoma or Urothelial Carcinoma Patients |
Primary outcome
Proportion of subjects with successful isolation and ex-vivo expansion of MILs
Time frame: 30 days
A successful expansion will be greater than or equal to 50% viable and greater than or equal to 50% CD3 positive.
Results and safety
The study was stopped early (reason given: Study funding was withdrawn.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Abhishek Tripathi, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspirate in people with Renal Cell Carcinoma and Urothelial Carcinoma, run by University of Oklahoma 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 8 inclusion and 12 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 13 Dec 2023. 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: Study funding was withdrawn.). 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?
Proportion of subjects with successful isolation and ex-vivo expansion of MILs (time frame: 30 days). 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 13 Dec 2023.