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Brief Title: Investigating Marrow Infiltrating Lymphocytes in Renal Cell Carcinoma

Investigating Marrow Infiltrating Lymphocytes as a Source of Adoptive Cellular Therapy in Renal Cell Carcinoma and Urothelial Carcinoma

INTRODUCTION

  • Org Study ID: OU-SCC-WindMIL-001
  • Secondary ID: N/A
  • NTC ID: NCT04341740
  • Sponsor: 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.

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.


  • Overall Status
    Recruiting
  • Start Date
    July 2020
  • Phase
    Early Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Proportion of subjects with successful isolation and ex-vivo expansion of MILs

Primary Outcome 1 - Timeframe: 30 days

CONDITION

  • Renal Cell Carcinoma
  • Urothelial Carcinoma

ELIGIBILITY


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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Abhishek Tripathi, MD

Role: Principal Investigator

Affiliation: University of Oklahoma

Overall Contact

Name: Abhishek Tripathi, MD

Phone: 1-405-271-8777

Email: SCC-IIT-Office@ouhsc.edu

LOCATION

Facility Status Contact
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States 		Status: Recruiting Contact:
Ingrid Block, APRN
405-271-8777
Ingrid-Block@ouhsc.edu

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