Clinical trial · Interventional
Abraxane and Temodar Plus Genasense in Advanced Melanoma
A Pilot Study of Abraxane® (Albumin-bound Paclitaxel) and Temodar® (Temozolomide) Plus Genasense® (Oblimersen Sodium) in Subjects With Advanced Melanoma ("The ATG Study").
NCT00409383CI-TRIAL-00005736unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abraxane® (paclitaxel protein-bound particles for injectable suspension) | Drug | Paclitaxel | ALIAS |
| Genasense® (oblimersen) | Drug | — | UNRESOLVED |
| Temodar® (temozolomide) | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety based on adverse event reports and clinical laboratory findings
- timeFrame
- 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)
- measure
- Response rate (including rate of complete response)
- timeFrame
- At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
- measure
- Duration of response (including the rate of durable response)
- timeFrame
- At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
- measure
- Time to disease progression
- timeFrame
- At the end of each cycle during protocol therapy, with follow-up every 2 months for up to 2 years from date of registration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.