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SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated Clinical research trials and SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated. SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated clinical trial. Subjects often receive the most expert healthcare possible for their SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated.
Details: OBJECTIVES: - Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416. - Determine the toxicity of SU5416 in this patient population. - Determine the median and overall survival and time to progression in these patients receiving this treatment. OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed melanoma with documented metastatic disease - In transit metastases allowed - Lesion accessible for biopsy - Measurable disease - Greater than 20 mm by conventional techniques OR - Greater than 10 mm by spiral CT - Documented progressive disease by radiologic study or physical examination - Known history of CNS metastasis who have had treatment, are neurologically stable, and do not require intravenous antibiotics or anticonvulsants eligible provided oral steroids are not required and brain scan (CT or MRI) shows absence of active or residual disease - If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - WBC at least 3,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - Transaminases no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No uncompensated coronary artery disease - No history of myocardial infarction or severe/unstable angina within past 6 months - No severe peripheral vascular disease associated with diabetes mellitus - No deep venous or arterial thrombosis within past 3 months Pulmonary: - No pulmonary embolism within past 3 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other significant uncontrolled underlying medical or psychiatric illness - No serious active infections - No other malignancy within past 5 years except for curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No other concurrent chemotherapy - No other concurrent investigational antineoplastic drugs Endocrine therapy: - See Disease Characteristics Radiotherapy: - No prior radiotherapy to only site of measurable disease - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - Not specified Other: - No greater than 1 prior therapy for metastatic disease - At least 4 weeks since prior therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasGajewski, Study Chair, University of Chicago Cancer Research Center
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46601
United States
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
Additional Information:
Study ID Numbers: CDR0000068011; UCCRC-NCI-48,NCI-48
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006003
Other Stage 4 Melanoma Studies:
1. Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg
2. Biological Therapy in Treating Patients With Metastatic Melanoma
3. Vaccine Therapy in Treating Patients With Metastatic Melanoma
4. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
5. Surgery in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Illinois Clinical Trials
Other Evanston Clinical Trials
SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
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