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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genasense® (oblimersen) | Drug | 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). |
| |
| Abraxane® (paclitaxel protein-bound particles for injectable suspension) | Drug | 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 |
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| Temodar® (temozolomide) | Drug | Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6) |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna C Pavlick, MD | NYU MEDICAL CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Cancer Center | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C408162 | oblimersen |
| D000068196 | Albumin-Bound Paclitaxel |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| 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 |
| 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 |
| 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 |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |