NCT00070343Unknown不适用
Continuation Protocol For G3139 (Bcl-2 Antisense Oligonucleotide) And Dacarbazine In Patients With Malignant Melanoma Who Responded To This Combination In Protocol GM301
适应症
相关药物
试验速览
- 阶段
- 不适用
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as dacarbazine, use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may help dacarbazine kill more tumor cells by making them more sensitive to the drug.
PURPOSE: This clinical trial is studying how well giving oblimersen together with dacarbazine works in treating patients with advanced malignant melanoma that previously responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.
详细描述
OBJECTIVES:
Primary
- Provide continuation therapy with oblimersen (G3139) and dacarbazine to patients with advanced malignant melanoma who obtained response or stabilization of disease after prior treatment with this therapy on GENTA-GM301.
Secondary
- Determine serious adverse events in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced malignant melanoma
- •Unresectable or metastatic disease
- •Previously enrolled on GENTA-GM301 protocol
- •Complete or partial objective response or stable disease after completion of 8 courses of oblimersen (G3139) and dacarbazine on arm II of GENTA-GM301
- •Measurable or evaluable disease
- •No uncontrolled brain metastases or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3*
- •Platelet count at least 100,000/mm^3*
- •Hemoglobin at least 8 g/dL* NOTE: *Hematopoietic growth factor or transfusion independent
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Albumin at least 2.5 g/dL
- •PTT no greater than 1.5 times ULN
- •PT no greater than 1.5 times ULN OR
- •INR no greater than 1.3
- •No history of chronic hepatitis or cirrhosis
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular
- •No uncontrolled congestive heart failure
- •No active symptoms of coronary artery disease, defined as uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication
- •No New York Heart Association class III or IV heart disease
- •No cardiovascular signs and symptoms grade 2 or greater within the past 4 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other significant medical disease
- •No uncontrolled seizure disorder
- •No active infection
- •No uncontrolled diabetes mellitus
- •No active autoimmune disease
- •No known hypersensitivity to phosphorothioate-containing oligonucleotides or dacarbazine
- •No intolerance to prior oblimersen and dacarbazine, including discontinuation of protocol therapy due to 1 or more adverse events
- •HIV negative
- •Satisfactory venous access for a 5-day continuous infusion
- •Intellectually, emotionally, and physically able to maintain an ambulatory infusion pump
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior biologic therapy, immunotherapy, cytokine therapy, or vaccine therapy and recovered
- •No concurrent anticancer biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •No other concurrent anticancer chemotherapy
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bcl-2 Antisense Oligodeoxynucleotide G3139 and Paclitaxel in Treating Patients With Recurrent Small Cell Lung CancerLung CancerNCT00005032University of Chicago12
已完成
2 期
Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)Liver CancerNCT00047229University Health Network, Toronto27
已完成
2 期
Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive GliomaBrain and Central Nervous System TumorsNCT00005081Duke University
已完成
2 期
O6-benzylguanine And Carmustine in Treating Patients With Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00004072Case Comprehensive Cancer Center17
已完成
2 期
O6-benzylguanine and Carmustine in Treating Patients With Recurrent, Metastatic, or Locally Advanced Soft Tissue SarcomaSarcomaNCT00005066University of Chicago12