Abraxane and Temodar Plus Genasense in Advanced Melanoma

Melanoma Clinical Trial

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").

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00409383
• Other study ID #: GM108
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 7, 2006
• Last updated: November 4, 2011
• Start date: November 2006
• Est. completion date: June 2013

Study information

• Verified date: July 2010
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	New York University Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Correlations of drug concentrations, intracellular Bcl-2 content, and response		Cycle 1	No