Oblimersen in Treating Patients With Merkel Cell Carcinoma
Recurrent Neuroendocrine Carcinoma of the Skin, Stage I Neuroendocrine Carcinoma of the Skin, Stage II Neuroendocrine Carcinoma of the Skin
About this trial
This is an interventional treatment trial for Recurrent Neuroendocrine Carcinoma of the Skin
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed Merkel cell carcinoma Metastatic OR regionally recurrent disease Localized disease not amenable to curative therapy (surgery or radiotherapy) also allowed Measurable disease At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No known brain metastases Previously resected or irradiated brain metastases allowed if stable for at least the past 3 months and no evidence of neurological compromise exists Performance status - Karnofsky 60-100% Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 WBC >= 3,000/mm^3 AST/ALT =< 2.5 times upper limit of normal Bilirubin normal INR =< 1.5 Creatinine normal Creatinine clearance >= 60 mL/min No atrial fibrillation unless stable for at least the past 6 months No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Adequate venous access No peripheral neuropathy > grade 1 No active or ongoing infection No other concurrent uncontrolled illness No prior grade 3 or 4 anaphylactic reaction to phosphorothioate oligonucleotide No psychiatric illness or social situation that would preclude study compliance More than 3 weeks since prior chemotherapy and recovered More than 3 weeks since prior radiotherapy and recovered No prior radiotherapy to 25% or more of bone marrow More than 3 weeks since prior investigational therapy and recovered No prior oblimersen No other concurrent investigational agents No concurrent anticoagulation except 1 mg of warfarin for mediport patency No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (oblimersen sodium)
Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.