MelanomaPhase 1NCT00409383
Abraxane and Temodar Plus Genasense in Advanced Melanoma
A Phase 1 study testing Genasense® (oblimersen), Abraxane® (paclitaxel protein-bound particles for injectable suspension) and Temodar® (temozolomide) in people with Melanoma, run by Genta Incorporated at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Genasense® (oblimersen), Abraxane® (paclitaxel protein-bound particles for injectable suspension) and Temodar® (temozolomide)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Cancer Center
New York, New York, 10016
About this 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").
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
- Being tested
- Genasense® (oblimersen), Abraxane® (paclitaxel protein-bound particles for injectable suspension), Temodar® (temozolomide)
- Keywords
- Advanced Melanoma, Normal baseline LDH, Chemotherapy naive
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genasense® (oblimersen)Drug
Also called G3139
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)Drug
Also called albumin-bound paclitaxel
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)Drug
Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety based on adverse event reports and clinical laboratory findings
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 12,15, and 18 months from date of registration, with follow-up every 2 months for up to 2 years from date of registration
Correlations of drug concentrations, intracellular Bcl-2 content, and response
Measured: Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna C Pavlick, MD, Principal investigator, NYU MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409383
- Sponsor's protocol ID
- GM108
- Status last verified
- Jul 2010
- First submitted
- 7 Dec 2006
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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").
- ClinicalTrials.gov ID
- NCT00409383
- Acronym / sponsor ID
- GM108
- Conditions
- Melanoma
- Keywords
- Advanced Melanoma, Normal baseline LDH, Chemotherapy naive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genasense® (oblimersen)Also: G3139Cohorts 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). | Drug | – |
| Abraxane® (paclitaxel protein-bound particles for injectable suspension)Also: albumin-bound paclitaxelCohorts 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 | Drug | – |
| Temodar® (temozolomide)Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6) | Drug | – |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
Correlations of drug concentrations, intracellular Bcl-2 content, and response
Time frame: Cycle 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna C Pavlick, MD principal investigator
NYU MEDICAL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genasense® (oblimersen), Abraxane® (paclitaxel protein-bound particles for injectable suspension) and Temodar® (temozolomide) in people with Melanoma, run by Genta Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.