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Abraxane and Temodar Plus Genasense in Advanced Melanoma

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ClinicalTrials.gov Identifier: NCT00409383
Recruitment Status : Unknown
Verified July 2010 by Genta Incorporated.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2006
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated

Brief 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).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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").
Study Start Date : November 2006
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma


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)


Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Correlations of drug concentrations, intracellular Bcl-2 content, and response [ Time Frame: Cycle 1 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409383


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

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00409383     History of Changes
Other Study ID Numbers: GM108
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: July 2010

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Temozolomide
Oblimersen
Albumin-Bound Paclitaxel
Dacarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents