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Tocilizumab for Patients With Cancer and COVID-19 Disease

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: NCT04370834
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II expanded access trial will study how well tocilizumab works in reducing the serious symptoms including pneumonitis (severe acute respiratory distress) in patients with cancer and COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. COVID-19 can be associated with an inflammatory response by the immune system which may also cause symptoms of COVID-19 to worsen. This inflammation may be called "cytokine storm," which can cause widespread problems in the body. Tocilizumab is a medicine designed to block the action of a protein called interleukin-6 (IL-6) that is involved with the immune system and is known to be a key factor for problems with excessive inflammation. Tocilizumab is effective in treating "cytokine storm" from a type of cancer immunotherapy and may be effective in reducing the inflammatory response and "cytokine storm" seen in severe COVID-19 disease. Treating the inflammation may help to reduce symptoms, improve the ability to breathe without a breathing machine (ventilator), and prevent patients from having more complications.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Pneumonia Pneumonitis Severe Acute Respiratory Distress Syndrome Symptomatic COVID-19 Infection Laboratory-Confirmed Biological: Tocilizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 217 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tocilizumab in Hospitalized Cancer Patients With Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19)
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021


Arm Intervention/treatment
Experimental: Other (tocilizumab)
Patients receive tocilizumab IV over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a >= 1-category worsening on the 7-category ordinal scale from nadir.
Biological: Tocilizumab
Given IV
Other Names:
  • Actemra
  • Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer
  • MRA
  • R-1569
  • RoActemra




Primary Outcome Measures :
  1. Clinical outcome as evaluated by the 7-category Clinical Status Ordinal Scale [ Time Frame: At least 60 days, up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have an active cancer diagnosis or have completed therapy within 12 months of initiation of protocol specified therapy. This includes:

    • Subjects with a new cancer diagnosis who have not yet initiated cancer therapy
    • Subjects on active or have recently completed cancer-directed therapy including chemotherapy, radiation therapy, immunotherapy or hormonal therapy amongst others

      • Myelosuppressive chemotherapy for patients in remission (e.g., adjuvant chemotherapy for breast cancer, acute myeloid leukemia [AML] consolidation) is prohibited until clinical recovery (1 or 2 on the 7-category ordinal scale)
    • Subjects on any investigational therapy for their underlying cancer, investigational COVID-19 anti-viral agents, or convalescent serum aimed at treating COVID-19 disease are eligible. Investigators are reminded to check whether the other investigational study(s) the patient is participating on specifically exclude tocilizumab and to adjudicate best clinical management decision for the specific patient
    • Subjects who have undergone hematopoietic stem cell transplant within the past 12 months, or are continued on graft versus host disease (GVHD) therapy, are also eligible
  • COVID-19 Diagnosis: Patients hospitalized with COVID-19 pneumonia confirmed by:

    • Radiographic findings concerning for COVID-19 pneumonia AND
    • Confirmatory SARS-CoV-2 positive result using any testing assay, or (with or without a confirmatory test) with suspicion of COVID-19 disease owing to belonging to a high-risk demographic group or living and/or working in high-risk settings or with known exposure AND
    • Oxygen saturation (SpO2) on room air =< 93% or PaO2/FiO2 < 300 mmHg
  • Age >= 2 years
  • Patients must have adequate organ function as assessed by the treating investigator to administer tocilizumab
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 10 x institutional upper limit of normal
  • Patients with low blood counts attributable to cancer therapy or underlying malignancy are eligible
  • Patients may be on other therapies for COVID-19 including investigational and not limited to corticosteroids, azithromycin, chloroquine, hydroxychloroquine

    • For patients already enrolled on other investigational studies for COVID-19, study investigators should verify that co-enrollment on this study is permissible as per the eligibility of the other study
  • Human immunodeficiency virus (HIV)-infected patients are eligible for this trial unless they have opportunistic complications of acquired immunodeficiency syndrome (AIDS) other than the cancer they have
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, should be on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection should be on treatment if indicated
  • The effects of tocilizumab on the developing human fetus are unknown

    • Pregnancy: Based on animal data, may cause fetal harm. Tocilizumab may be given if in the physician's judgment the patient's life is threatened without potential effective therapy

      • Women of childbearing potential must agree to use birth control or remain abstinent for the duration of the study and for at least 28 days following the last dose of tocilizumab. Pregnancy tests should be done based on the discretion of the patient and physician.
      • Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother
      • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, for the duration of the study and for at least 28 days following the last dose of tocilizumab
  • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible

Exclusion Criteria:

  • Prior or concurrent utilization of IL-6 specific targeting strategies for treatment of COVID-19 that showed no benefit after maximum dosing; (patients who have only received 1 prior dose and there was evidence of potential benefit may be eligible)

    • This includes siltuximab, tocilizumab, and sarilumab
  • Known hypersensitivity or history of severe allergic reaction to tocilizumab or other monoclonal antibodies
  • Any serious medical condition or active uncontrolled infections (besides COVID-19) that, in the investigator's judgement, preclude the subject's safe participation in the study

    • Examples: Active tuberculosis (TB) infection
  • Active diverticulitis because of severe flairs in disease leading risk of bowel perforation
  • Patients in whom, in the opinion of the treating physician, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments, will be excluded from the study
  • Patients receiving or planning to receive any investigational agents other than tocilizumab are ineligible for this study, with the following exceptions:

    • Investigational agents directed at a patient's underlying cancer are allowed.
    • Investigational SARS-CoV-2 anti-viral agents
    • Convalescent serum directed at COVID-19 disease

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): NCT04370834


Locations
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United States, Maryland
National Cancer Institute Recruiting
Rockville, Maryland, United States, 20850
Contact: Richard F. Little       littler@mail.nih.gov   
Principal Investigator: Richard F. Little         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Jennifer L. Holter-Chakrabarty         
United States, Washington
Valley Medical Center Recruiting
Renton, Washington, United States, 98055
Contact: Site Public Contact    425-228-3440    research@valleymed.org   
Principal Investigator: John A. Ellerton         
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Richard F Little National Cancer Institute (NCI)
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04370834    
Other Study ID Numbers: NCI-2020-02987
NCI-2020-02987 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
TRC-10446 ( Other Identifier: National Cancer Institute )
TRC-10446 ( Other Identifier: CTEP )
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Laboratory Infection
Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Infection
Occupational Diseases
Immunoglobulins
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs