This study is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of combination treatment with Temodar®, Genasense®, and Abraxane® in chemotherapy-naïve subjects with advanced melanoma and normal lactate dehydrogenase (LDH).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Cohorts 1 and 2: Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 7 days (Week 1) and beginning again on Day 22 and continuing for 7 days (Week 4); Cohort 3: Genasense 900 mg as a 1-hour intravenous infusion on Day 1, 4, 8, and 11 (Weeks 1 and 2) and Day 22, 25, 29, and 32 (Weeks 4 and 5).
Cohorts 1 and 2: Abraxane 175 mg/m2 or 260 mg/m2 as a 30-minute intravenous infusion on Day 8 and Day 29 following end of Genasense continuous infusion; Cohort 3: Abraxane 175 mg/m2 as a 30-minute intravenous infusion on Day 4 and Day 25 following end of Genasense 1-hour infusion
New York University Cancer Center
New York, New York, United States
Safety based on adverse event reports and clinical laboratory findings
Time frame: During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy
Response rate (including rate of complete response)
Time frame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
Duration of response (including the rate of durable response)
Time frame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
Time to disease progression
Time frame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
Incidence of brain metastasis
Time frame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
Survival
Time frame: 12,15, and 18 months from date of registration, with follow-up every 2 months for up to 2 years from date of registration
Correlations of drug concentrations, intracellular Bcl-2 content, and response
Time frame: Cycle 1
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Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)