Clinical trial NCT00412581 (phase 1, status: completed)
Conditions: melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: lenalidomide, dacarbazine
SMILES: NC1=CC=CC2=C1CN(C1CCC(=O)NC1=O)C2=O, N1C=CN=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet all of the following inclusion criteria to be eligible for
             enrollment into the study: Understand and voluntarily sign an informed consent
             document.

          -  Age >/= 18 years at the time of signing Informed Consent.

          -  Be able to adhere to the study visit schedule and other protocol requirements.

          -  Histological documentation of malignant melanoma with evidence of metastatic disease.

          -  For the 10 patients enrolled at the MTD, at least one measurable lesion must be
             present.

          -  ECOG performance status of 0,1,2.

          -  Laboratory tests within these ranges: a) Absolute neutrophil count >/=
             1,500/microliter b) Platelet count >/= 100,000/microliter, c) Serum creatinine </= 1.5
             mg/dL, d) Total bilirubin </= 1.5 mg/dL, e) AST (SGOT)/ALT (SGPT) </= 2 x upper limit
             of normal (ULN)

          -  Females of childbearing potential (FCBP)† must agree to use two reliable forms of
             contraception simultaneously or to practice complete abstinence from heterosexual
             intercourse during the following time periods related to this study. FCBP must have
             two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting
             study drug. Male Subjects: Must agree to use a latex condom during sexual contact with
             females of childbearing potential while participating in the study and for at least 28
             days following discontinuation from the study even if he has undergone a successful
             vasectomy.

          -  All acute toxic effects (excluding alopecia) of any prior therapy must have resolved
             to < or = to grade 1 (NCI CTCAE v3.0). (not listed in protocol synopsis)

          -  Patients must be able to take medications orally.

        Exclusion Criteria:

          -  The presence of any of the following will exclude a patient from study enrollment:
             Pregnant or lactating females.

          -  Any serious medical condition, including psychiatric illnesses that will prevent the
             patient from signing the informed consent or place the patient at an unacceptable risk
             if he/she participates in the study.

          -  Prior treatment with systemic chemotherapy. Patients who have received prior
             immunotherapy, including thalidomide, or radiotherapy remain eligible. Lesions within
             a prior field of radiation may only be used as indicator lesions if there has been
             evidence of disease progression at that site.

          -  Prior history of malignancies (except for basal cell or squamous cell carcinoma of the
             skin or carcinoma in situ of the cervix or breast) unless the patient has been free of
             the disease for at least 3 years.

          -  Use of thalidomide or biologic response modifier therapy within 14 days of Day 1,
             Cycle 1.

          -  Prior >/= grade-2 allergic reaction to thalidomide.

          -  Prior desquamating rash while taking thalidomide.

          -  Any prior use of CC-5013.

          -  Concurrent use of any other anti-cancer agents.

          -  Radiation or surgical treatment of melanoma within 28 days of starting study
             treatment.

          -  Active infection.

          -  Central nervous system (CNS) metastases.

          -  Patients with >/= grade-2 neuropathy.

          -  Patients with known HIV positivity or AIDS-related illness.