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Study funding was withdrawn.
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| Name | Class |
|---|---|
| WindMIL Therapeutics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow Aspirate | Procedure | bone marrow aspiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abhishek Tripathi, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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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.
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| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |