Abraxane and Temodar Plus Genasense in Advanced Melanoma
Status unconfirmed · Phase 1
Conditions studied: Melanoma
In brief
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).
Key facts
- Study ID
- NCT00409383
- Run by
- Genta Incorporated
- People needed
- 28
- Starts
- 2006-11-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2011-11-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York University Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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