Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
24

Summary

Conditions
  • Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Myelodysplastic Syndrome
  • Refractory Angioimmunoblastic T-Cell Lymphoma
  • Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Refractory T-Cell Non-Hodgkin Lymphoma
  • Refractory Mycosis Fungoides
  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Angioimmunoblastic T-Cell Lymphoma
  • Recurrent Mycosis Fungoides
  • Refractory Plasma Cell Myeloma
  • Recurrent Plasma Cell Myeloma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Refractory Acute Myeloid Leukemia
  • Refractory Anaplastic Large Cell Lymphoma
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of VSV-hIFNbeta-NIS in different treatment regimens (alone [group A] and in combination with ruxolitinib phosphate [ruxolitinib] [group B]) in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, or T-cell lym...

PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of VSV-hIFNbeta-NIS in different treatment regimens (alone [group A] and in combination with ruxolitinib phosphate [ruxolitinib] [group B]) in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, or T-cell lymphoma and in combination with ruxolitinib and cyclophosphamide (group C) in relapsed/refractory multiple myeloma patients. SECONDARY OBJECTIVES: I. To determine the safety profile of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib). II. To estimate clinical response rate of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib) 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 of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib) in patients with relapsed/refractory multiple myeloma, acute myeloid leukemia, or T-cell lymphoma overall and by disease type. CORRELATIVE 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- and post-virotherapy. VI. Assess presence of VSV in tumor and normal tissues subsequent to administration of intravenous (IV) VSV-IFNbeta-NIS. VII. To identify the best dose of VSV-hIFNbeta-NIS in the regimen being evaluated based on activity observed in the correlative measures described above in those dose levels identified as tolerable. OUTLINE: This is a dose escalation study of VSV-IFNbeta-NIS. Patients are assigned to 1 of 3 groups. GROUP A: Patients receive VSV-IFNbeta-NIS intravenously (IV) over 30 minutes on day 1. Patients undergo SPECT/CT scans at baseline, and at days 3 and 8 after VSV-IFNbeta-NIS infusion. GROUP B: Patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1 and ruxolitinib phosphate orally (PO) twice daily (BID) on days -1 to 9. Patients undergo SPECT/CT scans at baseline, and at days 3 and 8 after VSV-IFNbeta-NIS infusion. GROUP C: Patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1 and ruxolitinib phosphate PO BID on days -1 to 9. Patients also receive cyclophosphamide IV over 2 hours on day 2. Patients undergo SPECT/CT scans at baseline, and at days 3 and 8 after VSV-IFNbeta-NIS infusion. After completion of study treatment, patients are followed up for 28 days, and then every 3 months for up to 1 year or until progressive disease, then every 6 months for 1 year.

Tracking Information

NCT #
NCT03017820
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Martha Q Lacy Mayo Clinic in Rochester