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Abraxane and Temodar Plus Genasense in Advanced Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Genta Incorporated.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Genta Incorporated Identifier:
First received: December 7, 2006
Last updated: November 4, 2011
Last verified: July 2010
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).

Condition Intervention Phase
Drug: Genasense® (oblimersen)
Drug: Abraxane® (paclitaxel protein-bound particles for injectable suspension)
Drug: Temodar® (temozolomide)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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").

Resource links provided by NLM:

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 28
Study Start Date: November 2006
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Genasense® (oblimersen)
    Cohorts 1 and 2: Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 7 days (Week 1) and beginning again on Day 22 and continuing for 7 days (Week 4); Cohort 3: Genasense 900 mg as a 1-hour intravenous infusion on Day 1, 4, 8, and 11 (Weeks 1 and 2) and Day 22, 25, 29, and 32 (Weeks 4 and 5).
    Other Name: G3139
    Drug: Abraxane® (paclitaxel protein-bound particles for injectable suspension)
    Cohorts 1 and 2: Abraxane 175 mg/m2 or 260 mg/m2 as a 30-minute intravenous infusion on Day 8 and Day 29 following end of Genasense continuous infusion; Cohort 3: Abraxane 175 mg/m2 as a 30-minute intravenous infusion on Day 4 and Day 25 following end of Genasense 1-hour infusion
    Other Name: albumin-bound paclitaxel
    Drug: Temodar® (temozolomide)
    Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00409383

United States, New York
New York University Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
Genta Incorporated
Principal Investigator: Anna C Pavlick, MD NYU MEDICAL CENTER
  More Information

Responsible Party: Genta Incorporated Identifier: NCT00409383     History of Changes
Other Study ID Numbers: GM108
Study First Received: December 7, 2006
Last Updated: November 4, 2011

Keywords provided by Genta Incorporated:
Advanced Melanoma
Normal baseline LDH
Chemotherapy naive

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents processed this record on May 22, 2017