Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 1821 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma (WindMIL-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341740
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
WindMIL Therapeutics
Information provided by (Responsible Party):
University of Oklahoma

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Urothelial Carcinoma Procedure: Bone Marrow Biopsy Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Marrow Infiltrating Lymphocyte Isolation and Expansion
Each patient in both cohorts (RCC or UC) will undergo bone marrow aspiration under conscious sedation to withdraw 60 mL bone marrow aspirate.
Procedure: Bone Marrow Biopsy
bone marrow aspiration




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≥ 1.0 ×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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341740


Contacts
Layout table for location contacts
Contact: Lead GU Nurse 1-405-271-8777 SCC-IIT-Office@ouhsc.edu

Locations
Layout table for location information
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Ingrid Block, APRN    405-271-8777    Ingrid-Block@ouhsc.edu   
Contact: Lead GU Nurse    1-405-271-8777    SCC-IIT-Office@ouhsc.edu   
Principal Investigator: Abhishek Tripathi, MD         
Sponsors and Collaborators
University of Oklahoma
WindMIL Therapeutics
Investigators
Layout table for investigator information
Principal Investigator: Abhishek Tripathi, MD University of Oklahoma

Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04341740    
Other Study ID Numbers: OU-SCC-WindMIL-001
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
marrow infiltrating lymphocytes
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases