Clinical trial NCT00020839 (phase 3, status: terminated)
Conditions: melanoma (skin), metastatic cancer
ICD codes: C43.51, C43.9, C43.52, D03.51, C43.8, Z85.820, D03.52, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: temozolomide
SMILES: CSCC[C@H](N)C(O)=O
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed unresectable metastatic melanoma

               -  Must have asymptomatic brain metastasis that is not amenable to surgery or
                  stereotactic radiosurgery (gamma knife, Linac)

               -  Must have concurrent visceral/soft tissue metastases

          -  At least 1 site of measurable disease (not necessarily the brain metastasis)

          -  Documented evidence of disease progression defined by 1 of the following conditions:

               -  More than 25% increase in the size of at least 1 measurable lesion

               -  Appearance of a new lesion

               -  A significant increase in the size of nonmeasurable disease

          -  No neurological symptoms, including signs of elevated intracranial pressure

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 g/dL

        Hepatic:

          -  Bilirubin less than 1.5 times upper limit of normal (ULN)

          -  SGOT or SGPT less than 3 times ULN

          -  Alkaline phosphatase less than 3 times ULN

        Renal:

          -  Urea less than 1.5 times ULN

          -  Creatinine less than 1.5 times ULN

        Other:

          -  No frequent vomiting or medical condition (e.g., partial bowel obstruction) that would
             interfere with oral medication intake

          -  No other prior or concurrent malignancy except surgically cured carcinoma in situ of
             the cervix or basal cell or squamous cell skin cancer

          -  No uncontrolled infection

          -  HIV negative

          -  No AIDS-related illness

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No psychological, familial, sociological, or geographical condition that would
             preclude study

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Prior cytokine via isolated limb perfusion for local-regional melanoma allowed

          -  No other prior cytokine for metastatic melanoma

          -  No concurrent colony-stimulating factors, including epoetin alfa or filgrastim (G-CSF)

          -  No other concurrent immunologic or biologic therapy

        Chemotherapy:

          -  Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed

          -  No other prior chemotherapy for metastatic melanoma

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  Concurrent corticosteroids allowed during radiotherapy (arm II only)

          -  No concurrent hormonal therapy

        Radiotherapy:

          -  See Disease Characteristics

          -  No other concurrent radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  Recovered from the effects of any prior major surgery

        Other:

          -  No other concurrent investigational drugs