|
EPO906 Therapy in Patients with Advanced Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on EPO906 Therapy in Patients with Advanced Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. EPO906 Therapy in Patients with Advanced Melanoma Clinical research trials and EPO906 Therapy in Patients with Advanced Melanoma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like EPO906 Therapy in Patients with Advanced Melanoma. EPO906 Therapy in Patients with Advanced Melanoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a EPO906 Therapy in Patients with Advanced Melanoma clinical trial. Participants frequently obtain the most expert healthcare available for their EPO906 Therapy in Patients with Advanced Melanoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > EPO906 Therapy in Patients with Advanced Melanoma  EPO906 Therapy in Patients with Advanced Melanoma
EPO906 Therapy in Patients with Advanced Melanoma
For Condition: Melanoma
Status: Completed
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria The following patients may be eligible for this study: - Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation) - Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis) - Must have a life expectancy of greater than three (3) months - Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment - Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment - Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed). Exclusion Criteria The following patients are not eligible for this study: - Patients with choroidal ocular melanoma - Patients with symptomatic CNS metastases or leptomeningeal involvement - Patients with renal or hepatic dysfunction - Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1 - Patients with severe cardiac insufficiency - Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports - Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study - Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy) - Patients receiving chemotherapy within the last four weeks - History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ - Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae - HIV+ patients - Pregnant or lactating females.
Total Enrollment: 48
Location and Contact Information:
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
UPMC Health Systems
Pittsburgh, Pennsylvania, 15213
United States
Oklahoma Oncology, Inc.
Tulsa, Oklahoma, 74104
United States
Additional Information:
Study ID Numbers: CEPO906A-2206;
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035165
Other Melanoma Studies:
1. gp100 and MART-1 Peptide Vaccine for Metastatic Melanoma
2. A Phase II study of PI-88 in Patients with Advanced Melanoma
3. Study of Karenitecin (BNP1350) to treat Malignant Melanoma
4. gp100 and MART-1 Peptide Vaccine for Metastatic Ocular Melanoma
5. Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
Related Studies:
Other Melanoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
EPO906 Therapy in Patients with Advanced Melanoma
|
|
|
|
|
|
|
|
