Abraxane and Temodar Plus Genasense in Advanced Melanoma

NCT00409383 | Unknown Phase 1

• 1 other identifier: GM108
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Melanoma

Keywords

Advanced Melanoma; Normal baseline LDH; Chemotherapy naive

Outcome Measures

Primary Outcomes (1)

• Safety based on adverse event reports and clinical laboratory findings

  During protocol therapy prior to the start of and during each cycle and up to 30 days after last dose of protocol therapy

Secondary Outcomes (6)

• Response rate (including rate of complete response)

  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)

  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

  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

  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

  12,15, and 18 months from date of registration, with follow-up every 2 months for up to 2 years from date of registration

Interventions

Genasense® (oblimersen) DRUG

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).

Also known as: G3139

Abraxane® (paclitaxel protein-bound particles for injectable suspension) DRUG

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

Also known as: albumin-bound paclitaxel

Temodar® (temozolomide) DRUG

Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

New York University Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

oblimersen; Albumin-Bound Paclitaxel; Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Anna C Pavlick, MD

  NYU MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 8, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 7, 2011

Record last verified: 2010-07

Locations

US (1)