Abraxane and Temodar Plus Genasense in Advanced Melanoma - Full Text View

Sponsored by:	Genta Incorporated
Information provided by:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT00409383

Purpose

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
Melanoma	Drug: Genasense® (oblimersen) Drug: Abraxane® (paclitaxel protein-bound particles for injectable suspension) Drug: Temodar® (temozolomide)	Phase I

MedlinePlus related topics: Melanoma

Drug Information available for: Paclitaxel Temozolomide Oblimersen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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").

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:	February 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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)

Abraxane 175 mg/m2 or 260 mg/m2 as a 30-minute intravenous infusion on Day 8 and Day 29 following end of Genasense infusion

Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409383

Contacts

Contact: Anna C Pavlick, DO	(212) 731-5431	Anna.Pavlick@NYUMC.org
Contact: Matthew Volm, MD

Locations

United States, New York
New York University Cancer Center	Recruiting
New York, New York, United States, 10016
Contact: Juliet B Escalon, RN, OCN, ANP 212-731-5402 juliet.escalon@nyumc.org
Principal Investigator: Anna C Pavlick, DO

Sponsors and Collaborators

Genta Incorporated

Investigators

Principal Investigator:

Anna C Pavlick, MD

NYU MEDICAL CENTER

More Information

No publications provided

Responsible Party:	New York University Cancer Institute ( Anna Pavlick, DO )
Study ID Numbers:	GM108
Study First Received:	December 7, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00409383 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

Advanced Melanoma
Normal baseline LDH
Chemotherapy naive

Study placed in the following topic categories:

Antimitotic Agents
Temozolomide
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Paclitaxel
Neoplasms, Germ Cell and Embryonal

Nevus, Pigmented
Tubulin Modulators
Neuroepithelioma
Nevus
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Antimitotic Agents
Temozolomide
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Paclitaxel
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on May 07, 2009