Abraxane and Temodar Plus Genasense in Advanced Melanoma

Genta Incorporated

Status and phase

Unknown

Phase 1

Conditions

Melanoma

Treatments

Drug: Temodar® (temozolomide)

Drug: Abraxane® (paclitaxel protein-bound particles for injectable suspension)

Drug: Genasense® (oblimersen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00409383

GM108

Details and patient eligibility

About

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).

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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