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Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 Clinical research trials and Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301. Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 clinical trial. Human subjects frequently get the finest healthcare available for their Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301 condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301  Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
For Condition: stage 3 melanoma,Stage 4 Melanoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Clinical trial to study the effectiveness of combining oblimersen with dacarbazine in treating patients who have advanced malignantmelanoma that previously responded to treatment with oblimersen and dacarbazine on clinical trial GENTA-GM301.
Details: 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. OUTLINE: This is a nonrandomized, open-label, multicenter, continuation study. Patients receive oblimersen (G3139) IV continuously on days 1-5 and dacarbazine IV over 1 hour on day 5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients who complete 8 courses of treatment may receive additional courses at the discretion of the physician. Patients are followed every 2 months for up to 2 years after initiation of GENTA-GM301 protocol. PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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: Age - Any age Performance status - ECOG 0-2 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 Hepatic - 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 Renal - 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 Other - 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 Endocrine therapy - No concurrent chronic corticosteroids (average dose of at least 20 mg/day of prednisone or equivalent) Radiotherapy - At least 4 weeks since prior radiotherapy and recovered - No concurrent anticancer radiotherapy Surgery - At least 4 weeks since prior major surgery and recovered Other - At least 4 weeks since other prior therapy and recovered - More than 3 weeks since prior experimental therapy (except for GENTA-GM301 protocol) - No intervening systemic therapy for melanoma since completion of GENTA-GM301 protocol therapy - No other concurrent anticancer therapy, including investigational therapy - No concurrent immunosuppressive drugs - No concurrent anticoagulation therapy - Concurrent warfarin (1 mg/day) for central line prophylaxis is allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnGlaspy, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting John Glaspy 310-825-1274
Additional Information:
Study ID Numbers: CDR0000331927; UCLA-0307016,GENTA-GM214
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070343
Other Stage 3 Melanoma Studies:
1. Interferon alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
2. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
3. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
4. Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other stage 3 melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Oblimersen and Dacarbazine in Treating Patients With Advanced Malignant Melanoma That Has Responded to Treatment on Clinical Trial GENTA-GM301
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