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E7070 in Treating Patients With Stage IV Melanoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about E7070 in Treating Patients With Stage IV Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. E7070 in Treating Patients With Stage IV Melanoma Clinical research trials and E7070 in Treating Patients With Stage IV Melanoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including E7070 in Treating Patients With Stage IV Melanoma. E7070 in Treating Patients With Stage IV Melanoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a E7070 in Treating Patients With Stage IV Melanoma clinical trial. Human subjects often get the best healthcare possible for their E7070 in Treating Patients With Stage IV Melanoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > E7070 in Treating Patients With Stage IV Melanoma  E7070 in Treating Patients With Stage IV Melanoma
E7070 in Treating Patients With Stage IV Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): EORTC Early Clinical Studies Group , EORTC Melanoma Cooperative Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.
Details: OBJECTIVES: I. Determine the therapeutic activity of E7070 in terms of objective response, duration of response, and progression-free survival of patients with metastatic melanoma. II. Determine the acute side effects of this drug in these patients. III. Determine the pharmacokinetic parameters of this drug in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive E7070 IV over 1 hour. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks. PROJECTED ACCRUAL: A total of 19-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage IV melanoma; Metastatic disease - At least 1 bidimensionally measurable target lesion by CT scan - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 2 weeks since prior blood transfusions; At least 2 weeks since prior growth factors; At least 6 weeks since prior experimental vaccine therapy; No prior immunotherapy for metastatic disease; No concurrent anticancer immunotherapy - Chemotherapy: No prior chemotherapy for metastatic disease; No other concurrent anticancer chemotherapy - Endocrine therapy: No concurrent anticancer hormonal therapy - Radiotherapy: No concurrent anticancer radiotherapy except palliation for pain control or other reasons (e.g., bronchial obstruction or ulcerating skin lesions) with no curative intent - Surgery: Not specified - Other: At least 6 weeks since prior adjuvant or neoadjuvant therapy; At least 4 weeks since prior experimental drugs; At least 2 weeks since prior and no concurrent coumarin anti-coagulants, terfenadine, cisapride, cyclosporine, tacrolimus, theophylline, diazepam, sulfonylurea anti-diabetics, phenytoin, or carbamazepine; No other concurrent experimental agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2; WHO 0-2 - Life expectancy: Not specified - Hematopoietic: Hemoglobin greater than 10 g/dL; Neutrophil count greater than 2,000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present); Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Renal: Creatinine no greater than 1.7 mg/dL - Cardiovascular: Clinically normal cardiac function; No history of severe or unstable ischemic heart disease 12 lead ECG normal - Other: No history of unstable systemic disease; No concurrent uncontrolled diabetes mellitus; No concurrent infection; No history of hypersensitivity to sulfonamides; No other malignancy within the past 5 years except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer; No psychological, familial, sociological, or geographical condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnSmyth, Study Chair, EORTC Early Clinical Studies Group
Centre Eugene Marquis
Rennes, , 35064
France
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Centre Leon Berard
Lyon, , 69373
France
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Kaiser Franz Josef Hospital
Vienna, , A-1100
Austria
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Institut Jules Bordet
Brussels, , 1000
Belgium
Western General Hospital
Edinburgh, Scotland, EH4 2XU
United Kingdom
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , 1093
Portugal
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Additional Information:
Study ID Numbers: CDR0000068573; EORTC-16005,EISAI-E7070-E044-205
Study Start Date: February 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014625
Other Recurrent Melanoma Studies:
1. Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
2. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
3. Gene Therapy in Treating Patients With Metastatic Melanoma
4. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
5. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Clinical Trials
Other Clermont-Ferrand Clinical Trials
E7070 in Treating Patients With Stage IV Melanoma
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