- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00409383
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
Study Type
Interventional
Enrollment (Anticipated)
28
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
-
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New York
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New York, New York, United States, 10016
- New York University Cancer Center
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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
No
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
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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
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12,15, and 18 months from date of registration, with follow-up every 2 months for up to 2 years from date of registration
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Correlations of drug concentrations, intracellular Bcl-2 content, and response
Time Frame: Cycle 1
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Cycle 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 7, 2006
First Posted (ESTIMATE)
December 8, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
November 6, 2011
Last Update Submitted That Met QC Criteria
November 4, 2011
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Temozolomide
- Albumin-Bound Paclitaxel
- Oblimersen
Other Study ID Numbers
- GM108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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