Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Maria Liljefors
With
Karolinska Institutet
Swedish Institute for Infectious Disease Control
Cyto Pulse Sciences, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histological confirmed AJCC stage II or III colorectal cancer
Resection of the primary tumour without evidence of remaining macroscopic disease
Allowable standard chemotherapy or radiotherapy in AJCC stage III completed minimum 2 months prior study entry
Patients recruited from vaccination with CEA66 plasmid DNA must have completed trial at 18 months if immune response is proven or proven to be non-immune responders in two consecutive immunoassays.
Age \>18 years
Karnofsky performance \>80%
Life expectancy of greater than 6 months
Normal organ and marrow function
Normal thyroid function as measured by serum T3, T4 and TSH
Normal echocardiogram regarding arrhythmias (chronic or treated atrial fibrillation allowed)
No concurrent treatment (chemotherapy or biological) may be planned during protocol treatment
Women or men of reproductive potential must agree to use adequate contraception prior to study entry and for up to 3 months after the last injection
Ability to understand and the willingness to sign an informed consent document
You may not be if
Immunotherapy or systemic corticosteroids within 8 weeks prior to entering the study
Chemotherapy or radiotherapy within 2 months prior to entering the study
Known hypersensitivity to GM-CSF
Previous splenectomy or radiation therapy of the spleen
Pregnancy or nursing
HIV seropositivity
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic intracranial disease, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
History of severe neurological, cardiovascular, renal, hepatic, respiratory, bone marrow dysfunction, organ graft or autoimmune disease (treated or not)
Concomitant medication with an anticoagulant (acetylsalicylic acid and low-molecular weight heparin in prophylactic dose allowed)
Other malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Cardiac demand pacemakers or surgically implanted defibrillators.
Patients that has any metal implants in the area of the injection, (e.g. shoulder implant in the upper arm or shoulder girdle)
