Clinical Trials

MainTitle

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2019 by M.D. Anderson Cancer Center

Sponsor
M.D. Anderson Cancer Center

Collaborator
National Cancer Institute (NCI)

Information provided by (Responsible Party)
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier
NCT02479698

First received: June 19, 2015
Last updated: October 31, 2019
Last Verified: October 2019
History of Changes
Purpose

Purpose

This phase II trial studies how well donor cytotoxic T lymphocytes work in treating patients with malignancies with BK and/or JC virus. Cytotoxic T lymphocytes are made from donated blood cells that are grown in the laboratory and are designed to kill viruses that can cause infections in transplant patients and may be an effective treatment in patients with malignancies with BK and/or JC virus.

Condition Intervention Phase
Acquired Immunodeficiency Syndrome
BK Virus Infection
Human Immunodeficiency Virus
JC Virus Infection
Malignant Neoplasm
Merkel Cell Carcinoma
Merkel Cell Polyomavirus Infection
Viral Encephalitis

Biological : Allogeneic BK-specific Cytotoxic T-lymphocytes
Other : Laboratory Biomarker Analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Assessing the Effect of BK Specific CTL Lines Generated by Ex Vivo Expansion in Patients With BK Virus Infection and JC Virus Infection

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures

  • Response, defined as response (R) = (best response [R1] or second best response [R2]) [ Time Frame: Up to 56 days ]
    The method of Thall et al will be used to monitor the probabilities of response.
  • Incidence of acute graft-versus-host disease (GVHD) [ Time Frame: Within 28 days of the last dose of cytotoxic T lymphocytes (CTLs) ]
    The method of Thall et al will be used to monitor the probabilities of grade 3 or 4 GVHD.
  • Incidence of adverse events [ Time Frame: Up to day 100 ]
    Will be continuously monitored.
Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 12 months ]
    Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
  • Glomerular filtration rate [ Time Frame: Up to 12 months ]
    Each outcome will be evaluated by tabulation and by fitting a Bayesian statistical regression model for binary outcomes as a function of covar. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.

Estimated Enrollment: 100
Study Start Date: July 23, 2015
Estimated Study Completion Date: July 31, 2021
Estimated Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Treatment (BK-specific cytotoxic T lymphocytes)
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes IV over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.
Biological: Allogeneic BK-specific Cytotoxic T-lymphocytes

Given IV

Other Name:
  • Allogeneic BK-CTLs
  • Allogeneic BK-specific CTLs

Other: Laboratory Biomarker Analysis

Correlative studies

Detailed Description:

PRIMARY OBJECTIVE:
I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched BK specific cytotoxic T lymphocyte (CTL) lines (BK-CTLs) generated by ex vivo expansion to mediate antiviral activity in patients with any type of malignancies, and/or human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDs), and/or history of solid organ transplant with BK and JC infections.
SECONDARY OBJECTIVE:
I. To assess the persistence of the administered BK-CTLs generated by ex vivo expansion in patients with any type of malignancies, and/or HIV/AIDs, and/or history of solid organ transplant with BK and JC infections.
OUTLINE:
Patients receive allogeneic BK-specific cytotoxic T-lymphocytes intravenously (IV) over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 7 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.
After completion of study treatment, patients are followed up periodically for 12 months.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Patients with any type of malignancies; and/or HIV/AIDs; and/or history of solid organ transplant; and/or Merkel polyoma-virus related Merkel cell tumor(s) with measurable disease on imaging per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood polymerase chain reaction (PCR) positive for BK virus and/or JC viral encephalitis
  • Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day of prednisone
  • Patients who are currently receiving treatment with cidofovir, leflunomide, or other antiviral therapy with no response, will be eligible for CTL infusion
  • Once patients have completed 6-week safety and efficacy assessments after completion of the last anti-BK CTL infusion, patients will be eligible for enrollment on other supportive care protocols
  • Written informed consent from patient and/or signed assent from patient, parent or guardian
  • Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study


Exclusion Criteria:
  • Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment
  • Patients with other uncontrolled infections (except HIV/AIDS); for bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment; for fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment; progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection; persisting fever without other signs or symptoms will not be interpreted as progressing infection
  • Patients with active acute graft-versus-host disease (GVHD) grades II-IV

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02479698

Contacts

Contact:   Amanda L. Olson, MD 713-792-8750 ALOlson@mdanderson.org

Locations

United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Amanda Olson    713-792-8750
Principal Investigator: Amanda Olson

Sponsors and Collaborators

M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Amanda Olson M.D. Anderson Cancer Center
More Information

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website

Responsible Party: M.D. Anderson Cancer Center  
ClinicalTrials.gov Identifier: NCT02479698   History of Changes  
Other Study ID Numbers: 2014-0279  
  NCI-2015-01264  
  2014-0279  
  P30CA016672  
Study First Received: June 19, 2015  
Last Updated: October 31, 2019  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Infection
Communicable Diseases
Acquired Immunodeficiency Syndrome
HIV Infections
Carcinoma, Merkel Cell
Encephalitis, Viral
Polyomavirus Infections
Encephalitis
Immunologic Deficiency Syndromes
Virus Diseases

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.