Pilot Study of Interferon Alfa for Patients Who Have Received Cancer Vaccines
Condition: Cancer
Intervention: Interferon Alfa-2a
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research study is for people who have previously received cancer vaccines. The
      investigators are testing a form of therapy known as interferon alfa-2a, which is
      commercially available as the drug Roferon®-A, to see if it can be used to help boost the
      effects of the cancer vaccine and help the immune system attack the cancer.

      It is believed that the body's immune system can attack tumor cells and kill them. This is
      thought to be due to immune cells called T cells which can recognize special proteins on the
      surface of tumors as a signal to fight the cancer. However, the vaccine may not work very
      well if the protein signal is too weak for the T cells to find your tumors. The investigators
      think that interferon alfa-2a can signal the cancer cells in the body to make more proteins
      that may allow the T cells to recognize and kill the cancer cells better.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have received a cancer vaccine targeting tumor antigen.

          -  6 months following the last dose of the prior vaccine.

          -  Measurable disease defined by the RECIST criteria (lesions that can be accurately
             measured in at least one dimension with the longest diameter ≥ 20 mm using
             conventional techniques or ≥ 10 mm with spiral CT.)

          -  Karnofsky performance status greater than or equal to 70%

          -  Estimated life expectancy > 6 months.

          -  Age ≥ 18 years.

          -  Adequate, hematologic function with:

               -  WBC ≥ 3000 mm3

               -  hemoglobin ≥ 9 mg/dL (may transfuse or use erythropoietin to achieve this level)

               -  platelets ≥ 100,000/mm3

          -  Adequate, renal and hepatic function with:

               -  serum creatinine < 2.5 mg/dL

               -  bilirubin < 2.0 mg/dL

               -  SGOT/SGPT < 1.5 x upper limit of normal

          -  No prior grade 3 or 4 major organ or allergic toxicity attributable to the prior
             vaccine

          -  Ability to understand and provide signed informed consent that fulfills Institutional
             Review Board guidelines.

          -  Ability to return to Duke University Medical Center for adequate follow-up, as
             required by this protocol.

        Exclusion Criteria:

          -  Patients with concurrent chemotherapy, radiation therapy, or immunotherapy should be
             excluded. Patients may not have received interferon previously.

          -  Patients with either previously irradiated or new CNS (central nervous system)
             metastases at entry are excluded. Pre-enrollment head CT is not required if not
             indicated by clinical signs or symptoms.

          -  Patients with a history of auto-immune disease, such as but not restricted to,
             inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,
             scleroderma, or multiple sclerosis.

          -  Patients with serious intercurrent chronic or acute illness, such as cardiac disease,
             (NYHA class III or IV), hepatic disease, or other illness considered by the PI as
             unwarranted high risk for investigational drug treatment.

          -  Patients with a medical or psychological impediment to probable compliance with the
             protocol.

          -  Concurrent second malignancy other than non-melanoma skin cancer, or controlled
             superficial bladder cancer.

          -  Presence of an active acute or chronic infection including: an urinary tract
             infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral
             hepatitis (as determined by HBsAg and Hepatitis C serology). HIV patients are excluded
             based on immuno-suppression, which may render them unable to respond to the vaccine;
             patients with chronic hepatitis are excluded because of concern that hepatitis could
             be exacerbated by the injections.

          -  Patients on steroid therapy (or other immuno-suppressives, such as azathioprine or
             cyclosporin A) are excluded on the basis of potential immune suppression. Patients
             must have had 6 weeks of discontinuation of any steroid therapy (except that used as
             pre-medication for chemotherapy or contrast-enhanced studies) prior to enrollment.

          -  Patients with egg allergies or allergies to any component of the vaccine should be
             excluded from the protocol.

          -  Pregnant and nursing women should be excluded from the protocol since this research
             may have unknown and harmful effects on an unborn child or on young children. If the
             patient is sexually active, the patient must agree to use a medically acceptable form
             of birth control in order to be in this study. It is not known whether the treatment
             used in this study could affect the sperm and could potentially harm a child that
             maybe fathered while on this study.