Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy

• INCLUSION CRITERIA:

For cancer patients

• Adults over the age of 60.
• Documentation of positive diagnosis for any of the following:
• Non metastatic breast carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant radio / chemotherapy.
• Stage II or III (Dukes B or C) colon carcinoma following appropriate surgery and adjuvant chemotherapy.
• Stage II bladder carcinoma following neo-adjuvant radio / chemotherapy and appropriate surgery or following adjuvant radio / chemotherapy. Patients with recurrent tumors are not eligible.
• Appropriate therapy for each disease must be consistent with the latest NCCN Clinical Practice Guidelines in Oncology available at the web site:

http://www.nccn.org/professionals/physician_gls/f_guidelines.asp

• Completed cancer specific therapy (including surgery, radiotherapy and/or chemotherapy) a minimum of 4 weeks prior to entry. (Subjects with hormone receptor positive breast carcinoma maintained on hormonal therapy following chemotherapy and radiation are eligible).
• Completed cancer specific therapy at most 6 months prior to entry.
• Reasonable expectation that no chemotherapy will be given in the subsequent 6 months (PI's discretion).
• AST and ALT < 3 times the upper limit of normal.
• Bilirubin < 1.5 (except in cases of Gilbert's disease).
• Absolute Neutrophil Count greater than l000 / mm(3).
• Platelet count greater than 75K.
• INR/PTT within 1.5 times upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)
• Serum creatinine within 1.5 times upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)
• CPK within 2.5 times upper limit of normal (CTCAE 4.0 grade 1 abnormality is acceptable)
• Serum albumin greater or equal to 3g/dl (CTCAE 4.0 grade 1 abnormality is acceptable)
• Serum electrolytes within normal limits (CTCAE 4.0 grade 1 abnormality is acceptable)
• Karnofsky performance status greater or equal to 70%.

For healthy volunteers

• Adults over the age of 60.
• CBC with differential, Electrolytes, BUN and Creatinine, Liver panel, mineral panel, all within normal limits for age or, at most, a CTCAE 4.0 grade 1 abnormality,
• Absolute Neutrophil Count greater than l000 / mm(3).
• Platelet count greater than 75K.
• Karnofsky performance status greater or equal to 70%.
• Subjects with chronic but adequately treated and stable medical conditions (such as stable hypertension, hyperlipidemia, diabetes, hypothyroidism, etc) may be eligible (PI discretion): stable medical condition defined as no hospitalization, no new diagnoses and no significant adjustment of medications in the 3 months preceding enrollment.

EXCLUSION CRITERIA FOR ALL PARTICIPANTS:

• Subjects with significant heart disease defined as:
• Significant coronary arterial disease
• myocardial infarction in the last 6 months, angina in the previous 3 months,
• Troponin elevation at level of myocardial infarction as defined by the manufacturer
• Ischemic changes on ECG
• Atrio-ventricular block greater than 1st degree, in absence of pacemaker,
• QTc greater than 480ms (CTCAE 4.0 grade 1 abnormality is acceptable),
• History of ventricular arrhythmia,
• Left Ventricular Ejection Fraction below the institutional limit of normal,
• Positive serology for HTLV I, HIV, hepatitis B, or hepatitis C infection including a positive hepatitis B serology indicative of previous immunization (i.e. HBs Ab positive and HBc Ab negative),
• Life expectancy of less than 6 months,
• History of autoimmune disease: patients with vitiligo or endocrine disease controlled by replacement therapy including, diabetes, thyroid and adrenal disease may be enrolled,
• Patients requiring chronic immunosuppressive therapy (including corticosteroids) for any medical condition,
• Patients with splenomegaly or history of proliferative hematologic disease.
• Prior allogeneic Hematopoietic Stem Cell transplantation or solid organ transplantation,
• Inability or refusal to practice contraception during therapy (as physiologically relevant),
• History of medical or psychiatric disease which, in the view of the principal investigator, would preclude safe treatment,
• Patient with cognitive impairment,
• Previous exposure to Hepatitis A or B vaccines,
• Subjects who received a DT immunization in the previous 5 years,
• History of anaphylaxis or serious allergic reactions to previous administration of any of the vaccines,
• Known hypersensitivity to any of the following: diphtheria toxoid, neomycin, polymixin B, streptomycin, 2 phenoxyethanol, formaldehyde, aluminum hydroxide, yeast,
• Subjects with a history of allergy to influenza vaccine may still participate in the study but will not receive the influenza vaccine,
• Inability to give informed consent.