| Eligibility |
Inclusion Criteria:
- Subjects of all races with clinical Stage IV cancer of any type, staged according to
American Joint Commission on Cancer (AJCC), sixth edition, receiving any line of
standard treatment for the specific cancer and with stable disease or better for at
least two months will be invited to participate.
- Subjects of all races with clinical Stage IV cancer of any type, staged according to
American Joint Commission on Cancer (AJCC), sixth edition, who have no standard
treatment options for the specific cancer (Patients whose standard of care consists of
watchful waiting) and who fulfill the other eligibility criteria will be invited to
participate.
- Measurable or evaluable disease.
- Patients with bone-only disease will be allowed to participate.
- Ages 18 years and older.
- ECOG Performance status 0, 1 or 2.
- White blood cells (WBC) count = 3,000/mm3 within 3 weeks prior to registration
- Platelet count = 100,000/mm3 prior to registration
- Serum glutamic-oxaloacetic transaminase (SGOT) = 2 x institutional upper limit (IUL)
of normal obtained within 3 weeks prior to registration or Aspartate aminotransferase
test (AST) = 2 x institutional upper limit (IUL) of normal obtained within 3 weeks
prior to registration
- Bilirubin = 2 x institutional upper limit (IUL) of normal obtained within 3 weeks
prior to registration.
- Serum creatinine = 1.8 mg/dl obtained within 3 weeks prior to registration.
- Must sign an informed consent document approved by UAMS Institutional Review Board
(IRB).
Exclusion Criteria:
- Active infection requiring treatment with antibiotics.
- Existing diagnosis or history of organic brain syndrome that precludes participation
in the full protocol.
- Existing diagnosis or history of significant impairment of basal cognitive function
that might preclude participation in the full protocol.
- Other current malignancies. Subjects with prior history at any time of any in situ
cancer, including lobular carcinoma in situ of the breast, cervical cancer in situ,
atypical melanocytic hyperplasia or Clark I melanoma in situ, or basal or squamous
skin cancer are eligible, provided they are disease-free of these other malignancies
at the time of registration. Subjects with other malignancies - other than the one for
which they are being treated - are eligible if they have been continuously disease
free (from the old cancer) for = 5 years prior to the time of registration.
- Existing diagnosis or history of autoimmune disorders or conditions of
immunosuppression. This includes, but is not limited to, being treated with
corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when
used as an antiemetic in standard therapy]), continuous use of topical steroid creams
or ointments or any steroid-containing inhalers. Subjects who have been on systemic
steroids will require a 6-week washout period. Subjects who discontinue the use of
these classes of medication for at least 6 weeks prior to registration are eligible
if, in the judgment of the treating physician, the subject is not likely to require
these classes of drugs during the treatment period. Replacement doses of steroids for
subjects with adrenal insufficiency are allowed.
- Pregnancy or breast feeding, due to the unknown effects of peptide/mimotope vaccines
on a fetus or infant. Women of childbearing potential must have a negative urine
pregnancy test within 72 hours prior to receiving the first dose of study drug, and
must be counseled to use an accepted and effective method of contraception while on
treatment and for a period of 18 months after completing or discontinuing treatment.
Accepted methods include oral contraceptives, barrier method, IUDs, and abstinence.
- Any other significant medical or psychiatric conditions which, in the opinion of the
enrolling investigator, may interfere with consent or compliance of the treatment.
- Patients receiving checkpoint inhibitors.
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