Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Abraxane and Temodar Plus Genasense in Advanced Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlations of drug concentrations, intracellular Bcl-2 content, and response [ Time Frame: Cycle 1 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on March 01, 2015