Breast CancerPhase 2NCT00741039
Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
A Phase 2 study testing inactivated influenza vaccine and the 23- valent pneumococcal vaccine and inactivated influenza vaccine and the PPV23 vaccine (Pneumovax) in people with Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can get these infections. However, some people are at greater risk from the disease, including people 65 and older, the very young, and people with special health problems such as people with certain types of cancer, heart, lung… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- inactivated influenza vaccine and the 23- valent pneumococcal vaccine and inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patient must be > or = to 65 years of age.
- Patient may be an in patient or an out-patient.
- Patient must have a diagnosis of prostate, lung, or breast cancer.
- Patient must have a life expectancy of > or = to 6 months.
- Patient must have a Karnofsky score of >40%
- Patient must be willing to return to the hospital in 8-12 weeks following immunization for blood work.
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- Patients must have a platelet count of >75,000 for intramuscular injection.
- Patient may be of either gender and of any ethnic background.
- Patients must be able to understand the nature and risk of the proposed study and be able to sign consent.
- Volunteer eligibility:
- MSKCC employee
- Age > or = to 65 years of age
- No previous diagnosis of cancer except basal cell carcinoma, resected Stage I melanoma or in situ cervical carcinoma. Volunteers may have had a prior history of other cancers > 3 years which required only local resection, local radiation and/or hormonal therapy such as androgen blockade.
- Patients must be able to understand the nature and risk of the proposed study and be able to sign consent.
Who cannot join
- Karnofsky score <40%:
- Patients who have received an autologous or allogeneic HCT
- Active uncontrolled bacterial or fungal infection
- Hypersensitivity to egg protein (eggs or egg products), chicken proteins, or any component in the influenza vaccine
- Prior history of any life-threatening reaction after previous administration of any influenza vaccine or any component such as thimerosal (inclusion of thimerosal varies among packaging)
- Latex allergy if going to receive the influenza vaccine
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- On-going neurologic disorder (mental status change, uncontrolled seizures, encephalopathy)
- Treatment or planned treatment with cyclophosphamide, ifosphamide, or > or = to 1 mg/kg prednisone or its equivalent 12 weeks within 12 weeks of vaccination.
- HIV-1,2 seropositive patients.
- Patients not signing informed consent.
- Patients receiving the seasonal influenza vaccine may not have had it within 6 months of enrollment
- Healthy controls exclusion:
- Volunteers ineligible to receive either vaccine
- Volunteers unwilling or unable to sign consent
- Hypersensitivity to egg protein (eggs or egg products), chicken proteins, or any component in the influenza vaccine
- Latex allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase II Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can get these infections. However, some people are at greater risk from the disease, including people 65 and older, the very young, and people with special health problems such as people with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the blood (bacteremia), and the covering of the brain (meningitis). People with the special health problems mentioned above are even more likely to die from the disease. Although there are drugs to treat these infections, they are not always effective. This makes prevention of the disease through vaccination even more important.
This study will look at the body's response to influenza and pneumococcal vaccination. We want to see how well they it will protect. Immunization is the same as vaccination. Our goal is to protect as much as we can. We are doing the study because more information is needed to see how well older patients with cancer respond to these vaccines and how well they protect against disease caused by influenza and pneumococcus.
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Being tested
- inactivated influenza vaccine and the 23- valent pneumococcal vaccine, inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)
- Keywords
- Breast, Lung, Prostate, Vaccine
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inactivated influenza vaccine and the 23- valent pneumococcal vaccineBiological
Patients >65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23-valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured, as will serum IgG levels and IgG subtypes. At 8-16 weeks after vaccination, post vaccine titers, CBC, lymphoid phenotype and function will be assessed.
inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)Biological
MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly)and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured. At approximately 8-16 weeks after vaccination, post vaccine titers will be measured again.
| Study group | Role | What they receive |
|---|---|---|
| 1, | Experimental | Patients > or = to 65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23 valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). Receives: Biological: inactivated influenza vaccine and the 23- valent pneumococcal vaccine |
| 2 | Experimental | MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). Receives: Biological: inactivated influenza vaccine and the PPV23 vaccine (Pneumovax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Response Rate of Patients > or = to 65 Yrs Diagnosed
For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).
Measured: 8-16 weeks following vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trudy Small, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741039
- Sponsor's protocol ID
- 08-005
- Status last verified
- Oct 2015
- First submitted
- 22 Aug 2008
- Last updated
- 20 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
- ClinicalTrials.gov ID
- NCT00741039
- Acronym / sponsor ID
- 08-005
- Conditions
- Breast Cancer, Lung Cancer, Prostate Cancer
- Keywords
- Breast, Lung, Prostate, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infections due to influenza and pneumococcus can be very serious and cause death. Anyone can get these infections. However, some people are at greater risk from the disease, including people 65 and older, the very young, and people with special health problems such as people with certain types of cancer, heart, lung, or kidney disease, or diabetes. Influenza can cause a very serious lung infection (pneumonia) and increase the risk of stroke and heart attacks. Pneumococcal disease can lead to serious infections in the lungs (pneumonia), the blood (bacteremia), and the covering of the brain (meningitis). People with the special health problems mentioned above are even more likely to die from the disease. Although there are drugs to treat these infections, they are not always effective. This makes prevention of the disease through vaccination even more important.
This study will look at the body's response to influenza and pneumococcal vaccination. We want to see how well they it will protect. Immunization is the same as vaccination. Our goal is to protect as much as we can. We are doing the study because more information is needed to see how well older patients with cancer respond to these vaccines and how well they protect against disease caused by influenza and pneumococcus.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, | Experimental | Biological: inactivated influenza vaccine and the 23- valent pneumococcal vaccinePatients > or = to 65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23 valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). |
| 2 | Experimental | Biological: inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Patient must be > or = to 65 years of age.
- Patient may be an in patient or an out-patient.
- Patient must have a diagnosis of prostate, lung, or breast cancer.
- Patient must have a life expectancy of > or = to 6 months.
- Patient must have a Karnofsky score of >40%
Key exclusion criteria (16 listed)
- Karnofsky score <40%:
- Patients who have received an autologous or allogeneic HCT
- Active uncontrolled bacterial or fungal infection
- Hypersensitivity to egg protein (eggs or egg products), chicken proteins, or any component in the influenza vaccine
- Prior history of any life-threatening reaction after previous administration of any influenza vaccine or any component such as thimerosal (inclusion of thimerosal varies among packaging)
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 |
|---|---|---|
| inactivated influenza vaccine and the 23- valent pneumococcal vaccinePatients >65 years of age with a diagnosis of prostate, lung, and/or breast cancer will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly) and/or the 23-valent pneumococcal vaccine (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured, as will serum IgG levels and IgG subtypes. At 8-16 weeks after vaccination, post vaccine titers, CBC, lymphoid phenotype and function will be assessed. | Biological | 1, |
| inactivated influenza vaccine and the PPV23 vaccine (Pneumovax)MSKCC employee volunteer controls > or = to 65 years of age without a cancer diagnosis will be immunized with the inactivated influenza vaccine (0.5 ml intramuscularly)and/or PPV23 vaccine (Pneumovax), (0.5 ml subcutaneously or intramuscularly). Prior to vaccination, titers against influenza and pneumococcus will be measured. At approximately 8-16 weeks after vaccination, post vaccine titers will be measured again. | Biological | 2 |
Primary outcome
Determine Response Rate of Patients > or = to 65 Yrs Diagnosed
Time frame: 8-16 weeks following vaccination.
For Pneumovax, complete response will be either seroconversion or a >3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Trudy Small, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing inactivated influenza vaccine and the 23- valent pneumococcal vaccine and inactivated influenza vaccine and the PPV23 vaccine (Pneumovax) in people with Breast Cancer and Lung Cancer, run by Memorial Sloan Kettering Cancer Center 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 14 inclusion and 16 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: finished, as of the sponsor's last update on 20 Nov 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine Response Rate of Patients > or = to 65 Yrs Diagnosed (time frame: 8-16 weeks following vaccination.). 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 20 Nov 2015.