EUCTR2007-003340-30-DE进行中（未招募）不适用
A multicenter, randomized, double-blind study of dacarbazine with or without Genasense in chemotherapy naïve subjects with advanced melanoma and low LDH (The AGENDA Trial)
Genta Incorporated0 个研究点目标入组 300 人开始时间: 2007年9月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The following criteria must be met before registration not more than 15 days prior to randomisation:
- •1. Histologically confirmed diagnosis of melanoma
- •2. Progressive disease that is not surgically resectable, or metastatic Stage IV disease
- •3. LDH 4. Chemotherapy naïve Note: Prior immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy is permitted.
- •5. Measurable disease defined as at least 1 tumor lesion that can be accurately and serially measured in at least 1 dimension (longest diameter to be recorded) and is >/= 20 mm with conventional techniques and >/= 10 mm with spiral CT, based on Response Evaluation Criteria in Solid Tumors (RECIST)
- •Lesions that are considered nonmeasurable include:
- •- Bone lesions
- •- Ascites and pleural/pericardial effusions
- •- Lymphangitis cutis/pulmonis
- •- Abdominal masses not confirmed and not followed by imaging studies
- •- Cystic lesions
- •- Tumors treated by irradiation or intra-tumor injection therapy without progression in that area or measurable disease outside that area
- •6. ECOG performance status 7. At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiotherapy, or cytokine, biologic, or vaccine therapy
- •8. Adequate organ function, defined as:
- •a. Absolute neutrophil count (ANC) = 1500/mm3
- •b. Platelet count = 100,000/mm3
- •c. Hemoglobin = 11 g/dL without need for hematopoietic growth factor or transfusion support
- •d. Serum creatinine = 1.5 x ULN or 24-hour creatinine clearance = 50 mL/min
- •e. Serum bilirubin = 1.5 x ULN
- •f. Aspartate aminotransferase (AST) = 2.5 x ULN
- •g. Alanine aminotransferase (ALT) = 2.5 x ULN
- •h. Alkaline phosphatase = 2.5 x ULN
- •i. Serum albumin = 3.0 g/dL
- •j. Prothrombin time (PT) = 1.5 x ULN (or international normalized ratio [INR] = 1.3)
- •k. Partial thromboplastin time (PTT) = 1.5 x ULN
- •9. At least 18 years of age
- •10. Venous access adequate to maintain a 5-day continuous intravenous infusion
- •11. Intellectual, emotional, and physical ability to maintain an ambulatory infusion pump.
- •12. In women of childbearing potential (that is, all women except for those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization), a negative serum pregnancy test within 7 days prior to randomization.
- •13. In subjects of childbearing potential (that is, all men and all women excluding women who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization), agreement to use a highly effective form of contraception (ie, one that has a failure rate of < 1%) throughout the treatment phase of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
- •2. Need for other anticancer treatment (such as chemotherapy, radiation, or biologic or investigational therapies) while receiving protocol therapy in this study
- •3. Primary ocular or mucosal melanoma
- •4. Bone-only metastatic disease
- •5. History or presence of brain metastasis or leptomeningeal disease
- •6. History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 or more years)
- •7. Significant medical disease other than cancer, such as: uncontrolled congestive heart failure; active symptoms of coronary artery disease (defined as uncontrolled arrhythmias or recurrent chest pain despite prophylactic medication); New York Heart Association Class III or IV disease; cardiovascular signs and symptoms >/= Grade 2 by common toxicity criteria (CTC) during the 4-week period prior to initiation of protocol therapy; uncontrolled seizure disorder; history of chronic hepatitis or cirrhosis; active infection; uncontrolled diabetes mellitus; requirement for chronic corticosteroid treatment with an average dose >/= 20 mg/day of prednisone (or equivalent); requirement for concurrent immunosuppressive drug(s); active autoimmune disease
- •8. Organ allograft
- •9. Known human immunodeficiency virus infection
- •10. Pregnancy or lactation
- •11. Known hypersensitivity to dacarbazine or phosphorothioate-containing oligonucleotides
- •12. Use of any experimental therapy within 3 weeks prior to screening evaluations.
研究者
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