Abraxane and Temodar Plus Genasense in Advanced Melanoma

November 4, 2011 updated by: Genta Incorporated

A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").

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).

Study Overview

Status

Unknown

Conditions

Melanoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10016
    - New York University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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

Outcome Measure	Time Frame
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	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	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	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	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	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	Cycle 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Investigators

Principal Investigator: Anna C Pavlick, MD, NYU Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

December 7, 2006

First Submitted That Met QC Criteria