Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma

NCT04341740 | Terminated DMC

• 1 other identifier: OI-SCC-WINDMIL-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma; Urothelial Carcinoma

Keywords

marrow infiltrating lymphocytes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: Bone Marrow Aspirate

Interventions

Bone Marrow Aspirate PROCEDURE

bone marrow aspiration

Renal Cell Carcinoma or Urothelial Carcinoma Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• WindMIL Therapeutics: collaborator

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Abhishek Tripathi, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: July 22, 2020
• Primary Completion: March 9, 2021
• Study Completion: April 9, 2021
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)