Clinical trial NCT01200004 (phase 1, status: terminated)
Conditions: advanced cancers
ICD codes: K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: azacitidine, lenalidomide, grifola frondosa
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O
Reason stopped: 
    slow accrual.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed diagnosis of an advanced
             solid tumor refractory to standard treatment or for which no standard therapy is
             available.

          2. Patients must have ECOG performance status 2 or better (0-2).

          3. Patients must have normal organ and marrow function as defined: Absolute lymphocyte
             count > 1,000 /uL, Absolute neutrophil count > 1,500 /uL, Platelets > 75,000 /uL,
             Bilirubin </= 1.5 * ULN and AST and/or ALT </= 2.5 * the institutional upper limit of
             normal (ULN), </= 5 * ULN for patients with liver metastases, Serum creatinine within
             normal limits; if abnormal, then a calculated creatinine clearance >/= 50 mL/min

          4. Patients must be able to understand and be willing to sign an IRB-approved written
             informed consent document.

          5. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again
             within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7
             days) and must either commit to continued abstinence from heterosexual intercourse or
             begin TWO acceptable methods of birth control, one highly effective method and one
             additional effective method AT THE SAME TIME, at least 28 days before she starts
             taking lenalidomide.FCBP must also agree to ongoing pregnancy testing. Men must agree
             to use a latex condom during sexual contact with a FCBP even if they have had a
             successful vasectomy. A female of childbearing potential is a sexually mature woman
             who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
             naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any
             time in the preceding 24 consecutive months).

          6. Patients must be 18 years of age or older since the safety and dosages of these study
             drugs has not been demonstrated in the pediatric population. Exception: patients who
             are 13 years old or older and have more than 50 kg of body weight will be eligible
             after consultation with their pediatric attending.

          7. Life expectancy greater than 3 months based on the attending physician's discretion.

          8. All study participants must be registered in the mandatory RevAssist program, and be
             willing and able to comply with the requirements of RevAssist.

        Exclusion Criteria:

          1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable
             angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis,
             or psychiatric illness/social situations that would limit compliance with study
             requirements.

          2. History of stroke or transient ischemic attack within 6 months prior to study
             enrollment and significant vascular disease (e.g., aortic aneurysm, aortic dissection)
             and symptomatic peripheral vascular disease.

          3. History of allergic reactions to the study drugs or their analogs.

          4. Patients that have had any treatment specific for tumor control within 3 weeks of
             study drug treatment or: a. within 2 weeks if cytotoxic agents were given weekly b.
             within 6 weeks for nitrosoureas or mitomycin C c. within 4 half-lives for targeted
             agents with half lives and pharmacodynamic effects lasting less than 5 days (that
             includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and
             other similar agents) d. failed to recover from toxic effects of any therapy prior to
             study entry

          5. Concurrent known immunosuppressors.

          6. Inability to swallow oral medication.

          7. Pregnant or breastfeeding women.

          8. Concurrent enrollment on another research study.

          9. Known hepatitis B and C infection, HIV infection and autoimmune disorders.

         10. Subjects with known moderate or severe renal impairment will be excluded if creatinine
             clearance < 60 ml/min.