A Multicenter Phase II Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Glyco-Recombinant Human IL-7 in Older Subjects Following Chemotherapy

Inclusion Criteria

- 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.