Clinical trial NCT04341740: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma
Official title: Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma
Urothelial Carcinoma
Keywords: marrow infiltrating lymphocytes
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: WindMIL Therapeutics
First posted: 2020-04-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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 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.

Eligibility criteria: 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:

  * 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 Criteria:

* 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.

Primary outcomes:
measure: Proportion of subjects with successful isolation and ex-vivo expansion of MILs
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Abhishek Tripathi, MD
role: PRINCIPAL_INVESTIGATOR
References: