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Phase II Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older


Phase 2
65 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Prostate Cancer

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Trial Information

Phase II Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Determine resp rate of pts > or = to 65 yrs diag with common adult tumors to the killed influenza including the killed H1N1 & or the 23-valent pure polysaccharide vaccine, Pneumovax, c/w to healthy controls > or = to 65 yrs w/o cancer.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Trudy Small, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-005

NCT ID:

NCT00741039

Start Date:

August 2008

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Prostate Cancer
  • Breast
  • Lung
  • Prostate
  • Vaccine
  • Breast Neoplasms
  • Influenza, Human
  • Lung Neoplasms
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021