Status:
TERMINATED
Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
WindMIL Therapeutics
Conditions:
Renal Cell Carcinoma
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04341740
Start Date
July 22 2020
End Date
April 9 2021
Last Update
December 13 2023
Active Locations (1)
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1
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104