ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
Information source: Louis Stokes VA Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Shingles
Intervention: ZOSTAVAX (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Louis Stokes VA Medical Center Overall contact: David Canaday, M.D., Phone: 216-368-8901, Email: dxc44@case.edu
Summary
This study evaluates if the shingles vaccine works in those persons that receive it before
they receive chemotherapy for solid organ tumors. Half of the participants will receive the
ZOSTAVAX shingle vaccine and half of the participants will not received anything.
Clinical Details
Official title: A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Measuring the Efficacy of ZOSTAVAX in chemotherapy patients (Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT)Measuring the safety of ZOSTAVAX given to chemotherapy patients (Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures
Detailed description:
This study is a single blind randomized clinical trial measuring the immunologic efficacy of
ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after
chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine
vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the
parameters of the package insert and ACIP recommendations, placebo vaccine is not required
to access our key primary immunologic endpoint.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Solid organ tumor patients that have at least 14 days between entry into the study
with ZOSTAVAX vaccination and initial therapy for their malignancy that will include
chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation
therapy
- A plan for chemotherapy that at the onset at least an anticipated stop date within
3-6 months of our sample collection phase of the study
Exclusion Criteria:
- Prior history of HZ or shingles vaccine
- Systemic chemotherapy < 3 months prior to enrollment
- Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant,
or other cellular immunodeficiency state
- Those receiving immunomodulating drugs at the time of vaccination such as prednisone
methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha
inhibitors
- Widespread metastatic tumor with bone marrow involvement
- Indefinite duration palliative chemotherapy subjects
- Inability to communicate with the study staff or bring unable to consent for
themselves
- History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other
components of the vaccine
Locations and Contacts
David Canaday, M.D., Phone: 216-368-8901, Email: dxc44@case.edu Additional Information
Starting date: May 2015
Last updated: May 14, 2015
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