Overview

This trial is active, not recruiting.

Condition melanoma
Treatments genasense® (oblimersen), abraxane® (paclitaxel protein-bound particles for injectable suspension), temodar® (temozolomide)
Phase phase 1
Sponsor Genta Incorporated
Start date November 2006
End date June 2013
Trial size 28 participants
Trial identifier NCT00409383, GM108

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Safety based on adverse event reports and clinical laboratory findings
time frame: During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy

Secondary Outcomes

Measure
Response rate (including rate of complete response)
time frame: 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)
time frame: At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
Time to disease progression
time frame: 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
time frame: 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
time frame: 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
time frame: Cycle 1

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").
Principal investigator Anna C Pavlick, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2011.
Information provided to ClinicalTrials.gov by Genta Incorporated.