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A Study of DPX-Survivac Vaccine Therapy in Patients With Recurrent Survivin-expressing DLBCL

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ClinicalTrials.gov Identifier: NCT02323230
Recruitment Status : Unknown
Verified December 2015 by ImmunoVaccine Technologies, Inc. (IMV Inc.).
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2014
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Brief Summary:
This phase 2 study is designed to assess the efficacy and safety of DPX-Survivac plus low dose cyclophosphamide in subjects with recurrent diffuse large B-cell lymphoma (DLBCL) who are not eligible for transplant.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Biological: DPX-Survivac Drug: Cyclophosphamide Phase 2

Detailed Description:
A multi-center treatment study assessing the efficacy and safety of an immunotherapeutic vaccine (DPX-Survivac) combined with low dose cyclophosphamide. Subjects with measurable, histologically proven DLBCL expressing survivin will be treated in this open-label, single arm study. Survivin is a protein commonly over-expressed in many types of cancer, including DLBCL.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Recurrent Survivin-Expressing Diffuse Large B-Cell Lymphoma (DLBCL)
Study Start Date : January 2015
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : February 2018


Arm Intervention/treatment
Experimental: DPX-Survivac + low dose cyclophosphamide Biological: DPX-Survivac
Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously

Drug: Cyclophosphamide
Low dose cyclophosphamide will be taken by mouth




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: approximately 6 months ]

Secondary Outcome Measures :
  1. Immune response [ Time Frame: 1 year ]
    levels of cell mediated immunity targeting the survivin epitopes

  2. Frequency of adverse events [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Subjects with histologically proven recurrent DLBCL. Subjects may have recurrence after primary or second treatment regimens for DLBCL. Subjects with recurrence at least 90 days post-autologous stem cell transplantation (ASCT) are eligible. Patients with partial response or measurable disease after first line therapy (who are not candidates for ASCT) or after second line therapy without disease progression may also be eligible.
  • Previous localized surgery, radiotherapy, and chemotherapy more than 21 days prior to SD0.
  • Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy (e.g. rituximab), other B cell depleting antibody therapy, or radioimmunotherapy (e.g. tositumomab or ibritumomab) if last administration is greater than 77 days prior to SD0.
  • Subjects must have at least one measurable site of disease.
  • Willing to undergo a pre-treatment and post-treatment tumor biopsy.
  • Subjects must have evidence of survivin expression in pre-treatment tumor sample.
  • A screening Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-1.
  • A life expectancy > 6 months.

Main Exclusion Criteria:

  • Patients eligible for possible curative therapies such as ASCT.
  • Patients undergoing concurrent chemotherapy, radiation therapy, or immunotherapy or who are currently on an investigational product/trial are excluded. There must be at least 21 days since completion of prior chemotherapy/radiation and at least 77 days since completion of immunotherapy until study treatment begins (SD0). Subjects must have recovered from all acute toxicities from prior treatment; peripheral neuropathy must be < grade 2.
  • Lactate dehydrogenase (LDH) greater than 2 times the upper limit of normal.
  • Patients with refractory disease after their last treatment (i.e. progression within 90 days).
  • Patients who have received prior survivin based vaccines.
  • Progressive CNS lymphoma requiring treatment within 84 days prior to SD0.
  • History of active autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years.

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): NCT02323230


Locations
Canada, Ontario
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT02323230     History of Changes
Other Study ID Numbers: ONC-DPX-Survivac-05
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: December 2015

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vaccines
Cyclophosphamide
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists