Clinical trial NCT00026520 (phase 2, status: completed)
Conditions: melanoma (skin)
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52
Drugs: thalidomide
SMILES: CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IV malignant melanoma

               -  Surgically incurable disease

          -  Measurable or evaluable disease

          -  No brain metastases by CT scan or MRI

               -  Prior brain metastases allowed only if completely resected and treated with whole
                  brain radiotherapy

          -  Must have received 1, and only 1, prior systemic therapy for metastatic disease

               -  Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy

        PATIENT CHARACTERISTICS:

        Age:

          -  Adult

        Performance status:

          -  Zubrod 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 75,000/mm^3

        Hepatic:

          -  SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN)

          -  Bilirubin no greater than ULN

        Renal:

          -  Creatinine no greater than 1.5 times ULN

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use 2 methods of effective contraception 4 weeks before, during,
             and for 4 weeks after study

          -  HIV negative

          -  No AIDS or HIV-1-associated complex

          -  No other serious illness

          -  No serious active infections

          -  No sensory neuropathy greater than grade 1

          -  No prior seizures or concurrent potential risk factors for the development of seizures

          -  No other prior malignancy within the past 5 years except adequately treated basal cell
             or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer currently in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

          -  At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or
             metastatic setting and recovered

          -  No concurrent filgrastim (G-CSF)

          -  No other concurrent biologic therapy

        Chemotherapy:

          -  See Disease Characteristics

          -  At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and
             recovered

          -  No concurrent chemotherapy

        Endocrine therapy:

          -  See Disease Characteristics

          -  At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting
             and recovered

          -  No concurrent hormonal therapy

          -  No concurrent systemic steroids (including creams)

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 21 days since prior radiotherapy and recovered

          -  Prior radiotherapy to all known sites of disease allowed if there is objective
             evidence of progression

          -  No concurrent radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  At least 21 days since prior surgery for primary or metastatic disease and recovered

          -  No concurrent surgery

        Other:

          -  At least 21 days since prior systemic therapy or combination regimen for metastatic
             disease and recovered

          -  At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered

          -  No other concurrent therapy

          -  No other concurrent investigational drugs

          -  No concurrent immunosuppressive medications

          -  Concurrent antihistamines allowed if no alternative medication available