NeoplasmsPhase 1NCT01695733
Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy
A Phase 1 study testing trivalent influenza vaccine in people with Neoplasms, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- trivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have biopsy-confirmed non-hematological malignancy
- Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
- Patients must be of age >=18 years.
- Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination
- Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
- Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination
- Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen
- Patients must not be on any other agents that can suppress the immune system
- Planned concurrent therapy with radiation
Show all 11Show fewer
- Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness
- Psychiatric illness/social situations that would limit compliance with study requirements
- Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response
- History of influenza-like illness, defined as a temperature > 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study
- Patient may not be scheduled to receive chemotherapy on a weekly basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Influenza Vaccination Response in Patients With Non-Hematological Malignancies
This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.
- Conditions
- Neoplasms
- Being tested
- trivalent influenza vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent influenza vaccineBiological
Also called Flushield, Fluvirin, Fluzone, Influenza Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Schedule A | Experimental | Influenza vaccination on the first day of chemotherapy Receives: Biological: trivalent influenza vaccine |
| Schedule B | Experimental | Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy Receives: Biological: trivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.
We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.
Measured: 4 weeks from the influenza vaccine
Secondary outcomes (1)
Report the presence of post-vaccination adverse events
Measured: 4 weeks from the influenza vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: no longer had funding to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saiama Waqar, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695733
- Sponsor's protocol ID
- 201010722
- Status last verified
- Aug 2018
- First submitted
- 26 Sep 2012
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination Response in Patients With Non-Hematological Malignancies
- ClinicalTrials.gov ID
- NCT01695733
- Acronym / sponsor ID
- 201010722
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no longer had funding to continue
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies the best time to administer the influenza vaccine to patients with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different times relative to chemotherapy may affect how well it works to help the body build an immune response and prevent influenza in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schedule A | Experimental | Biological: trivalent influenza vaccineInfluenza vaccination on the first day of chemotherapy |
| Schedule B | Experimental | Biological: trivalent influenza vaccineInfluenza vaccination 1 week (+/- 1 day) prior to chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have biopsy-confirmed non-hematological malignancy
- Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy
- Patients must be of age >=18 years.
- Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination
- Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document
Key exclusion criteria (11 listed)
- Patients who have already received the influenza vaccine during the season in which they are considered for eligibility will be excluded
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies
- Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination
- Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen
- Patients must not be on any other agents that can suppress the immune system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trivalent influenza vaccineAlso: Flushield, Fluvirin, Fluzone, Influenza Vaccine | Biological | Schedule A, Schedule B |
Primary outcome
Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.
Time frame: 4 weeks from the influenza vaccine
We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.
1 secondary outcome
Report the presence of post-vaccination adverse events
Time frame: 4 weeks from the influenza vaccine
Results and safety
The study was stopped early (reason given: no longer had funding to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saiama Waqar, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing trivalent influenza vaccine in people with Neoplasms, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no longer had funding to continue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule. (time frame: 4 weeks from the influenza vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.