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Surgery vs. Chemotherapy in Patients with Stage IV Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Surgery vs. Chemotherapy in Patients with Stage IV Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Surgery vs. Chemotherapy in Patients with Stage IV Melanoma Clinical research trials and Surgery vs. Chemotherapy in Patients with Stage IV Melanoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Surgery vs. Chemotherapy in Patients with Stage IV Melanoma. Surgery vs. Chemotherapy in Patients with Stage IV Melanoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Surgery vs. Chemotherapy in Patients with Stage IV Melanoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Surgery vs. Chemotherapy in Patients with Stage IV Melanoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery vs. Chemotherapy in Patients with Stage IV Melanoma  Surgery vs. Chemotherapy in Patients with Stage IV Melanoma
Surgery vs. Chemotherapy in Patients with Stage IV Melanoma
For Condition: Melanoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will compare the effectiveness of surgery versus drug therapy in prolonging life and improving the quality of life of patients with stage IV melanoma. Currently, no treatment strategy can definitely improve the quality or length of life of patients with this advanced disease. Patients 16 years of age and older with metastatic melanoma (melanoma that has spread from the original site to other parts of the body) whose disease has worsened while receiving interleukin-2 (IL-2) therapy, or who are ineligible to receive high-dose IL-2 therapy may participate in this study. Candidates must have disease that can be treated surgically. Patients with primary ocular or mucosal melanoma are excluded from this study. Candidates will be screened with a medical history and physical examination, CT or MRI of the chest, abdomen and pelvis, MRI of the brain, PET imaging, blood and urine tests, EKG, review of pathology slides, and pregnancy testing for women capable of bearing children. Participants will be randomly assigned to one of the following treatment groups: Surgery Patients in this group will have all known tumors removed surgically. After surgery, they will have x-rays every 3 to 6 months to check for new tumors. If the cancer recurs, repeat surgery will be considered, or chemotherapy with dacarbazine or cisplatin, or both, may be offered. Patients for whom these drugs are not appropriate will be advised of other research protocols that may be available. Chemotherapy Patients in this group will receive dacarbazine or cisplatin, or both, depending on their previous drug treatment. Chemotherapy will be given in 3-week cycles. Dacarbazine will be infused over 30 to 60 minutes through a catheter (plastic tube) placed in a vein. Infusions will be given on the first 3 days of each cycle. Cisplatin will also be given through a vein over 30 minutes on the first 3 days of each cycle. Patients receiving cisplatin will come to the Clinical Center the night before the infusions to receive intravenous fluids throughout the night, continuing until 3 hours after completing cisplatin in order to protect the kidneys from the effects of the chemotherapy. X-rays will be taken every 3 months to determine the response to treatment. Chemotherapy will continue until the tumors disappear or the side effects of the treatment become too severe. Patients whose tumors grow during treatment will be taken off the study and referred to another protocol if an appropriate one is available. Surgical removal of some or all of the tumors will be considered if they are causing significant problems. Patients in either group who stop treatment may be asked to return to NIH for follow-up evaluations every 3 to 4 months for 2 years and then every 6 months until the end of 5 years. Participants will also be asked to complete two quality of life questionnaires before beginning treatment and again at the 3-month, 6-month, and 12-month clinic visits. The questionnaires are designed to evaluate how people in this study feel, how well they are able to perform their usual activities, and how the treatment affects their general health and well-being.
Details: Selected patients with Stage IV melanoma which is refractory to interleukin-2 based immunotherapy or who are IL-2 ineligible and that have metastatic disease amenable to complete surgical excision will be randomized to receive metastasectomy or chemotherapy with dacarbazine and/or cisplatin (patients that have had prior therapy with dacarbazine and cisplatin will be referred following randomization for other investigational protocols). Patients that progress following surgery will be considered for repeat resection or chemotherapy with dacarbazine and/or cisplatin. The end point of the study is overall patient survival. Patients receiving chemotherapy will also be followed for tumor response. All patients will be followed for time to progression, overall survival and health-related quality of life. The morbidity associated with each treatment strategy will be monitored.
Eligibility:
Study Type: Interventional, Treatment, Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient age greater than or equal to 16 with measurable metastatic melanoma who has progressed while receiving or after receiving treatment with IL-2 based therapy or who is ineligible to receive high dose IL-2 therapy and has an expected survival of greater than three months will be considered. Patients must have metastatic disease, which is amenable to complete surgical resection and an estimated mortality from surgery of less than 5%. Serum creatinine of 1.6 mg/dl or less or a creatinine clearance of at least 70 ml/min. WBC 3000/mm(3) or greater, OR ANC greater than or equal to 1500/mm(3) Platelet count 100,000 mm(3) or greater ECOG performance status of less than or equal to 2 Patients of both genders must be willing to practice effective birth control during this trial. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their melanoma. Patients who have developed new disease within six months of undergoing a previous complete metastasectomy will be excluded. Other patients who have undergone previous complete metastasectomy will be included. Who have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems, or renal systems which significantly increase a patient's operative risk. Who are pregnant Who are known to be positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody because of their potential for toxicity secondary to chemotherapy, or who have any form of primary or secondary immunodeficiency. Who have brain metastasis. Who have disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, iliac nodes) sites only. Who have disease that requires palliative surgery or radiation Who have a solitary pulmonary nodule as the sole site of metastatic disease. Who have primary ocular or mucosal melanoma.
Total Enrollment: 74
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030279; 03-C-0279
Study Start Date: September 3, 2003
Record last reviewed: August 11, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068939
Other Melanoma Studies:
1. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
2. Study of Talabostat in Advanced Melanoma
3. Microarray Analysis for Human Genetic Disease
4. EPO906 Therapy in Patients with Advanced Melanoma
5. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
Related Studies:
Other Melanoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Surgery vs. Chemotherapy in Patients with Stage IV Melanoma
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