CCI-779 in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: temsirolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: temsirolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma