Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma

This is an interventional treatment trial for Melanoma focused on measuring Sorafenib, Temsirolimus, Stage IV, recurrent, unresectable, non-choroidal origin, CCI-779, BAY43-9006, metastatic melanoma Read More

Inclusion Criteria:

• Histologically or cytologically confirmed melanoma, meeting 1 of the following criteria: recurrent or unresectable stage III disease, stage IV disease, non-choroidal origin.
• Tumor must be accessible to biopsy unless appropriate tumor sample collection has occurred within the past 3 months and patient agrees to provide these samples for this study.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Bilirubin normal
• Creatinine normal or creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after completion of study treatment.
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib or temsirolimus.
• No uncontrolled hypertension, defined as systolic blood pressure > 140 mm Hg on 2 separate days < 1 week prior to study entry OR diastolic pressure > 90 mm Hg on 2 separate days < 1 week prior to study entry.
• No evidence of bleeding diathesis or coagulopathy.
• No condition that would impair the ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication; requirement for IV alimentation; or active peptic ulcer disease).
• No uncontrolled illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness or social situations that would limit study compliance.
• No traumatic injury within the past 3 weeks.
• No more than 1 prior systemic chemotherapy regimen for metastatic melanoma (Phase II).
• No prior sorafenib, temsirolimus, or any other agents targeting raf, vascular endothelial growth factor (VEGF)/VEGF receptor, or mTOR (Phase II).
• No prior surgical procedures affecting absorption.
• At least 3 weeks since prior major surgery.
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) for melanoma and recovered.
• At least 4 weeks since prior radiotherapy and recovered.
• Prior biologic or immunotherapeutic regimens allowed.
• Prior regional chemotherapy regimens (e.g., isolated limb perfusion) allowed but only 1 prior regional chemotherapy regimen allowed if all target lesions are within the prior regional treatment field.
• No concurrent enzyme-inducing antiepileptic drugs including, but not limited to, any of the following: phenytoin, carbamazepine, phenobarbital, rifampin or Hypericum perforatum (St. John's wort).
• No concurrent prophylactic hematopoietic colony-stimulating factors.
• No other concurrent investigational agents.
• No other concurrent anticancer agents or therapies for this cancer.
• No concurrent full-dose anticoagulation (i.e., warfarin, IV heparin, or low-molecular weight heparin).
• No concurrent grapefruit or grapefruit juice.
• No concurrent combination antiretroviral therapy for HIV-positive patients.
• Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided prothrombin time (PT) international normalized ratio (INR) < 1.1 times upper limits of normal (ULN).
• Unidimensionally measurable disease >= 20 mm by conventional techniques or >= 10 mm by spiral computed tomography (CT) scan (longest diameter to be recorded) and margins of visible cutaneous metastatic lesions should be clearly defined and measured in at least one dimension as >= 10 mm.
• No known brain metastases unless the following criteria are met: no radiographical evidence of recurrences in the brain >= 3 months after complete resection of the brain metastases, asymptomatic brain metastases stable for >= 3 months since whole-brain radiation therapy and/or stereotactic radiosurgery and must not require steroid for brain metastases.
• White Blood Count (WBC) >= 3,000/mm³
• Absolute neutrophil count >= 1,500/mm³
• Platelet count >= 100,000/mm³
• Serum cholesterol =< 350 mg/dL
• Triglycerides =< 400 mg/dL
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 times upper limit of normal.
• No peripheral neuropathy > grade 2.
• At least 5 years since prior chemotherapy for other types of cancer.