Clinical Trial: VSV-hIFNbeta-NIS in Treating Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, or T-cell Lymphoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myelo
Brief Summary: This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus carrying the human NIS and IFN beta genes (VSV-hIFNbeta-sodium iodide symporter [NIS]) in treating patients with multiple myeloma, acute myeloid leukemia, or T-cell lymphoma that has come back or does not respond to treatment. A virus, called VSV-hIFNbeta-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of VSV-hIFNbeta-NIS in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, or T-cell lymphoma.
SECONDARY OBJECTIVES:
I. To determine the safety profile of VSV-hIFNbeta-NIS. II. To estimate clinical response rate in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, or T-cell lymphoma overall and by disease type.
III. To estimate progression-free and overall survival in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, or T-cell lymphoma overall and by disease type.
TERTIARY OBJECTIVES:
I. To determine the time course of viral gene expression and virus elimination, and the biodistribution of virally infected cells at various times points after infection with VSV-hIFNbeta-NIS using planar and single photon emission computed tomography (SPECT)/computed tomography (CT) imaging.
II. To assess virus replication, viremia, viral shedding in urine and respiratory secretions, and virus persistence after systemic administration of VSV-hIFNbeta-NIS.
III. To characterize the pharmacodynamics (PD) of VSV-IFNbeta-NIS by way of measuring serum interferon-beta and also vesicular stomatitis virus (VSV)-real time (RT)-polymerase chain reaction (PCR) of VSV-IFNbeta-NIS.
IV. Assess CD8+ T cell (both general and VSV-IFNbeta-NIS specific) and natural killer (NK) cell responses.
V. Gene expression analysis pre- a
Sponsor: Mayo Clinic
Current Primary Outcome: Incidence of adverse events of grade 3 or higher assessed by the Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical response [ Time Frame: Up to 1 year ]The number of responses (complete response [CR], very good partial response, partial response [PR], or minimal response for multiple myeloma; CR, CR with incomplete recovery, cytogenetic complete response, PR for AML; CR or PR for TCL) will be summarized by simple descriptive summary statistics.
- Overall survival [ Time Frame: From registration to death due to any cause, assessed up to 1 year ]The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type).
- Progression-free survival [ Time Frame: From registration to disease progression or death due to any cause, assessed up to 1 year ]The distribution of survival time will be estimated using the method of Kaplan-Meier (overall, by dose level, and by disease type).
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: January 9, 2017
Date Started: April 4, 2017
Date Completion: January 2021
Last Updated: May 22, 2017
Last Verified: January 2017