Status:
UNKNOWN
Abraxane and Temodar Plus Genasense in Advanced Melanoma
Lead Sponsor:
Genta Incorporated
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00409383
Start Date
November 1 2006
End Date
June 1 2013
Last Update
November 7 2011
Active Locations (1)
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1
New York University Cancer Center
New York, New York, United States, 10016