A Phase II Study of G3139 (Genasense ™) in Patients With Merkel Cell Carcinoma

Date de début de l'étude : 1 janvier 2004

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