Melanoma
Conditions
Keywords
Advanced Melanoma, Normal baseline LDH, Chemotherapy naive
Brief summary
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).
Interventions
DRUGGenasense® (oblimersen)
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).
DRUGAbraxane® (paclitaxel protein-bound particles for injectable suspension)
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
DRUGTemodar® (temozolomide)
Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)
Sponsors
Genta Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with progressive, unresectable, or advanced melanoma who are considered to be candidates for systemic treatment with chemotherapy * Subjects will have measurable disease, an Eastern Cooperative Oncology Group Performance Status less than or equal to 2, and serum LDH less than or equal to 1.1 times the upper limit of normal, but will not have previously received cytotoxic chemotherapy * Prior immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy is permitted in the adjuvant and/or metastatic setting
Exclusion criteria
* Prior treatment with cytotoxic chemotherapy, including regional perfusion, or with Genasense®(oblimersen sodium)Injection * Nonmeasurable disease only * History or presence of brain metastasis or leptomeningeal disease * Significant medical disease other than cancer * Known human immunodeficiency virus infection * Pregnant or lactating * Known hypersensitivity to temozolomide, phosphorothioate-containing oligonucleotides, or products containing human albumin * Use of any experimental therapy within 3 weeks prior to baseline evaluations, Other anticancer treatment (such as chemotherapy, radiation, or biologic or investigational therapies) while receiving therapy in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety based on adverse event reports and clinical laboratory findings | During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (including the rate of durable response) | 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 | At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration |
| Response rate (including rate of complete response) | 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 | 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 | Cycle 1 |
| Incidence of brain metastasis | At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration |
Countries
United States
Outcome results
None listed