Back to resultsAbraxane and Temodar Plus Genasense in Advanced Melanoma
Primary Purpose
Melanoma
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Genasense® (oblimersen)
Abraxane® (paclitaxel protein-bound particles for injectable suspension)
Temodar® (temozolomide)
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Advanced Melanoma, Normal baseline LDH, Chemotherapy naive
Eligibility 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
Sites / Locations
- New York University Cancer Center
Outcomes
Primary Outcome Measures
Safety based on adverse event reports and clinical laboratory findings
Secondary Outcome Measures
Response rate (including rate of complete response)
Duration of response (including the rate of durable response)
Time to disease progression
Incidence of brain metastasis
Survival
Correlations of drug concentrations, intracellular Bcl-2 content, and response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00409383
Brief Title
Abraxane and Temodar Plus Genasense in Advanced Melanoma
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").
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Advanced Melanoma, Normal baseline LDH, Chemotherapy naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Genasense® (oblimersen)
Other Intervention Name(s)
G3139
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Abraxane® (paclitaxel protein-bound particles for injectable suspension)
Other Intervention Name(s)
albumin-bound paclitaxel
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Temodar® (temozolomide)
Intervention Description
Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Correlations of drug concentrations, intracellular Bcl-2 content, and response
Time Frame
Cycle 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna C Pavlick, MD
Organizational Affiliation
NYU MEDICAL CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Abraxane and Temodar Plus Genasense in Advanced Melanoma
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