Status:
COMPLETED
Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Lung Cancer
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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 ol...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00741039
Start Date
August 1 2008
End Date
August 1 2012
Last Update
November 20 2015
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065