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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

Page last updated: August 23, 2015

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