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) - AGENDA
- Conditions
- naïve subjects with advanced melanoma and low LDH.MedDRA version: 9.1Level: LLTClassification code 10025650Term: Malignant melanoma
- Registration Number
- EUCTR2007-003340-30-IT
- Lead Sponsor
- Genta Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
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 /= 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 /= 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 /= 50 mL/min e. Serum bilirubin /= 3.0 g/dL j. Prothrombin time (PT) 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
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;
- Women of childbearing potential and sexually active males must be advised to take precautions to prevent pregnancy during protocol therapy.
- All subjects must use an effective form of birth control during protocol therapy (except if the women is post menopause for > 1 year or surgically sterile). 11. Known hypersensitivity to dacarbazine or phosphorothioate-containing oligonucleotides 12. Use of any experimental therapy within 3 weeks prior to screening evaluations 13. Need for concomitant anticoagulant therapy with the exception of 1 mg/day of warfarin for central-line prophylaxis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare progression-free survival and overall survival in the dacarbazine plus Genasense treatment group and the dacarbazine plus placebo treatment group.;Secondary Objective: The secondary objectives of this study are to compare the 2 treatment groups with respect to the percentages of subjects with response and durable response, duration of response, and the safety of the 2 treatment regimens.;Primary end point(s): The primary endpoint is progression-free survival.
- Secondary Outcome Measures
Name Time Method