Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04379518
Status:
SUSPENDED
Last Update Posted:
2023-03-06
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rintatolimod and IFN Alpha-2b for the Treatment of COVID-19 in Cancer Patients
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Phase 1/2A Study of Rintatolimod and IFN Alpha Regimen in Cancer Patients With COVID-19
Status:
SUSPENDED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
working on revision to protocol
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the safety of the combination of intravenous (i.v.) rintatolimod administered with or without i.v. IFN alpha (recombinant interferon alfa-2b \[Intron A\]) in patients with cancer with coronavirus disease 2019 (COVID-19).
II. Determine the kinetics of viral load in nasopharyngeal swabs in the course of treatment and Days 7 and 14.
SECONDARY OBJECTIVES:
I. To assess the efficacy of the treatment combination in patients with cancer with COVID-19.
II. Determine the kinetics of viral load in the peripheral blood in the course of treatment and Days 7 and 14.
III. Determine the kinetics of changes of the immune subsets and circulating inflammatory mediators (including C-reactive protein \[CRP\], cytokines, chemokines, interferons) in peripheral blood in the course of treatment and Days 7 and 14.
IV. Determine the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R (PKR); oligoadenylate synthetase-2 (OAS2); RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats (IFIT1) and IFN-inducible transmembrane protein 3 (IFITM3), TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment.
OUTLINE: This is a phase I, dose-escalation study of recombinant interferon alfa-2b followed by a phase II study.
LEAD-IN PHASE: Patients receive rintatolimod IV over 2.5-3 hours on day 1 and day 3 (or 4).
Subsequent patients are randomized to 1 of 2 arms.
ARM I: Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on day 1 and on day 3 or 4 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive standard of care.
EXPANSION COHORT: Patients are randomized to 1 of 2 arms.
ARM III: Patients receive rintatolimod IV over 2.5-3 hours once.
ARM IV: Patients receive standard of care.
Patients are followed up at days 7, 14 and 30 after initiation of the study regimen.
I. To determine the safety of the combination of intravenous (i.v.) rintatolimod administered with or without i.v. IFN alpha (recombinant interferon alfa-2b \[Intron A\]) in patients with cancer with coronavirus disease 2019 (COVID-19).
II. Determine the kinetics of viral load in nasopharyngeal swabs in the course of treatment and Days 7 and 14.
SECONDARY OBJECTIVES:
I. To assess the efficacy of the treatment combination in patients with cancer with COVID-19.
II. Determine the kinetics of viral load in the peripheral blood in the course of treatment and Days 7 and 14.
III. Determine the kinetics of changes of the immune subsets and circulating inflammatory mediators (including C-reactive protein \[CRP\], cytokines, chemokines, interferons) in peripheral blood in the course of treatment and Days 7 and 14.
IV. Determine the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R (PKR); oligoadenylate synthetase-2 (OAS2); RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats (IFIT1) and IFN-inducible transmembrane protein 3 (IFITM3), TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment.
OUTLINE: This is a phase I, dose-escalation study of recombinant interferon alfa-2b followed by a phase II study.
LEAD-IN PHASE: Patients receive rintatolimod IV over 2.5-3 hours on day 1 and day 3 (or 4).
Subsequent patients are randomized to 1 of 2 arms.
ARM I: Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on day 1 and on day 3 or 4 in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive standard of care.
EXPANSION COHORT: Patients are randomized to 1 of 2 arms.
ARM III: Patients receive rintatolimod IV over 2.5-3 hours once.
ARM IV: Patients receive standard of care.
Patients are followed up at days 7, 14 and 30 after initiation of the study regimen.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-02317 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| I 659920 | OTHER | Roswell Park Cancer Institute | View | |
| P30CA016056 | NIH | None | https://reporter.nih.gov/quic… | View |