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

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 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:

MedlinePlus related topics: Melanoma

Drug Information available for: Paclitaxel Temozolomide

U.S. FDA Resources

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:

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

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

Cohorts 1-3: 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

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

More Information

No publications provided

Responsible Party:	Genta Incorporated
ClinicalTrials.gov 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:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Paclitaxel

Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 16, 2013