cci-779 in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of cci-779 in treating patients who have metastatic melanoma.

objectives: * determine the anti-tumor activity of cci-779, in terms of progression-free survival, in patients with metastatic melanoma. * determine the toxic effects of this regimen in these patients. outline: this is a multicenter study. patients receive cci-779 iv over 30 minutes on day 1. courses repeat every 7 days in the absence of disease progression or unacceptable toxicity. patients are followed for survival. projected accrual: approximately 40-50 patients will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed metastatic melanoma that is incurable by surgery, radiotherapy, or limb perfusion * measurable disease * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * the following are not considered measurable: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * inflammatory breast disease * lymphangitis cutis/pulmonis * abdominal masses not confirmed and followed by imaging techniques * cystic lesions * progressive disease * no prior or concurrent cns metastasis patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * more than 4 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin normal * ast and alt no greater than 2.5 times upper limit of normal * cholesterol no greater than 350 mg/dl (lipid-lowering therapy allowed) * triglycerides no greater than 300 mg/dl except for hydroxymethyl-glutaryl-coenzyme a reductase inhibitors renal: * creatinine normal or * creatinine clearance at least 60 ml/min cardiovascular: * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * hiv negative * no prior allergic reactions to compounds of similar chemical or biological composition to study drug * no ongoing or active infection * no seizure disorder * no autoimmune disease * no psychiatric illness or social situation that would preclude study * no other concurrent uncontrolled illness that would preclude study prior concurrent therapy: biologic therapy: * no more than 1 prior adjuvant biological therapy regimen * no more than 1 prior biological therapy regimen for advanced disease * at least 6 months since prior biological therapy or biochemotherapy and recovered * prior isolated limb perfusion with biological agent allowed if not to sole site of disease chemotherapy: * see biologic therapy * prior isolated limb perfusion with chemotherapy allowed if not to sole site of disease * no more than 1 prior chemotherapy-containing regimen for advanced disease, regardless of adjuvant therapy * may be in addition to 1 prior biologic regimen for advanced disease or * may have had 1 prior biochemotherapy regimen for advanced disease * at least 3 weeks since prior chemotherapy and recovered endocrine therapy: * at least 1 week since prior dexamethasone * no concurrent glucocorticosteroid therapy radiotherapy: * see disease characteristics surgery: * see disease characteristics other: * at least 1 week since prior phenobarbital, phenytoin, carbamazepine, or rifampin * at least 3 weeks since other prior agents to treat malignancy * at least 3 weeks since prior investigational agents * no other concurrent investigational agents * no concurrent drugs that are metabolized by or alter the level of cytochrome p450-3a

Keywords: stage iv melanoma recurrent melanoma