Abraxane and Temodar Plus Genasense in Advanced Melanoma
Phase 1
- Conditions
- Melanoma
- Registration Number
- NCT00409383
- Lead Sponsor
- Genta Incorporated
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 Correlations of drug concentrations, intracellular Bcl-2 content, and response Cycle 1 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 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
Trial Locations
- Locations (1)
New York University Cancer Center
🇺🇸New York, New York, United States