Clinical trial NCT00886457 (phase 1, status: terminated)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: decitabine and pegylated interferon-alfa 2b
SMILES: NC1=NC(=O)N(C=N1)[C@H]1C[C@H](O)[C@@H](CO)O1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patient must have a biopsy proven cancer, which is metastatic or unresectable, for
             which (in the opinion of the investigator), no curative or more effective treatment
             exists.

          2. Patient must have biopsy accessible tumor and must indicate willingness to undergo
             biopsies of tumor and normal skin on days 1, 15 and 29.

          3. Patient must have measurable disease by RECIST criteria by scans performed within 28
             days of study enrollment.

          4. Patient may not have untreated brain metastasis. Patients with previously treated
             brain metastasis must no longer be receiving steroid therapy for the treatment of
             their brain metastasis.

          5. Patient must have a Zubrod performance status of 0 - 2.

          6. Prior surgery, radiotherapy or chemotherapy is allowed. The patient must not have
             received chemotherapy, radiotherapy, surgery, biologic therapy or any other
             investigational drug for any reason within 28 days prior to registration. Concomitant
             treatment with other anti-cancer agents or radiotherapy, including investigational
             agents during the course of study treatment is not allowed.

          7. Patients with extensive pelvic irradiation or prolonged nucleoside analogue
             pretreatment are excluded due to increased risk for hematologic toxicity.

          8. Patient must have adequate liver function as defined by a serum bilirubin ≤ 1.5 x the
             institutional upper limit of normal (IULN), SGOT or SGPT ≤ 2.5 x the institutional
             upper limit of normal (or ≤ 5 x the institutional upper limit of normal if hepatic
             metastases is present) obtained within 14 days prior to registration.

          9. Patient must have an adequate renal function as defined by a serum creatinine ≤ 1.5 x
             the institutional upper limit of normal, as well as a calculated or measured
             creatinine clearance (CrCl) ≥ 50 ml/min.

         10. Patient must have an ANC > 1,500/μl, platelet count > 100,000/μl and hemoglobin > 9
             gm/dl (this may be achieved by transfusion if needed) obtained within 14 days prior to
             registration.

         11. All patients must be informed of the investigational nature of this study and must
             provide written acknowledgment of informed consent in accordance with institutional
             and federal guidelines.

         12. Both men and women of all races and ethnic groups are eligible for this trial.

         13. Patients must be ≥ 18 years of age.

        Exclusion Criteria:

          1. Class 3/4 cardiac problems as defined by the New York Heart Association Criteria
             (e.g., congestive heart failure, myocardial infarction within 2 months of study).

          2. Severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes,
             uncontrolled chronic renal or liver disease, or active uncontrolled infection, e.g.,
             HIV).

          3. Patient must not be pregnant or nursing mothers because PEG-Intron or decitabine may
             be harmful to the developing fetus and newborn. Women/men of reproductive potential
             must agree to use an effective contraceptive method. Women of reproductive potential
             must have a negative serum pregnancy test within 7 days prior to registration.
             Postmenopausal women must be amenorrheic for at least 12 months to be considered of
             non-childbearing potential. Male and female patients of reproductive potential must
             agree to employ an effective barrier method of birth control throughout the study and
             for up to 3 months following discontinuation of study drug.

          4. Medical or psychological conditions that, in the opinion of the investigator, make the
             patient unable to tolerate or complete the treatment, or to grant reliable informed
             consent are not eligible for this study.

          5. No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             Stage I, II, or III 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.