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Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain 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 Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain Clinical research trials and Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain 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 Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain. Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain 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 Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain clinical trial. Subjects often receive the most expert healthcare possible for their Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain 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 > "T" Clinical Trials Conditions > Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain  Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
For Condition: Recurrent Melanoma,brain metastases,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): 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. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.
Details: OBJECTIVES: - Compare the efficacy of temozolomide with or without radiotherapy in terms of overall survival in patients with stage IV melanoma with asymptomatic brain metastases. - Compare the time to appearance of neurological symptoms in patients treated with these regimens. - Compare the progression-free survival of patients treated with these regimens. - Compare the quality of life and quality-adjusted survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to LDH levels (less than 225 U/L vs 225 U/L or more), concurrent metastases (visceral vs soft tissue), and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment continues every 4 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive temozolomide as in arm I and whole brain radiotherapy on days 8-12 and 15-19 during the first course of chemotherapy. Quality of life is assessed before beginning each course and then every 4 weeks after completion of study drug. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed unresectable metastatic melanoma - Must have asymptomatic brain metastasis that is not amenable to surgery or stereotactic radiosurgery (gamma knife, Linac) - Must have concurrent visceral/soft tissue metastases - At least 1 site of measurable disease (not necessarily the brain metastasis) - Documented evidence of disease progression defined by 1 of the following conditions: - More than 25% increase in the size of at least 1 measurable lesion - Appearance of a new lesion - A significant increase in the size of nonmeasurable disease - No neurological symptoms, including signs of elevated intracranial pressure PATIENT CHARACTERISTICS: Age: - 18 and over 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 10 g/dL Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT or SGPT less than 3 times ULN - Alkaline phosphatase less than 3 times ULN Renal: - Urea less than 1.5 times ULN - Creatinine less than 1.5 times ULN Other: - No frequent vomiting or medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake - No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - No uncontrolled infection - HIV negative - No AIDS-related illness - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior cytokine via isolated limb perfusion for local-regional melanoma allowed - No other prior cytokine for metastatic melanoma - No concurrent colony-stimulating factors, including epoetin alfa or filgrastim (G-CSF) - No other concurrent immunologic or biologic therapy Chemotherapy: - Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed - No other prior chemotherapy for metastatic melanoma - No other concurrent chemotherapy Endocrine therapy: - Concurrent corticosteroids allowed during radiotherapy (arm II only) - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics - No other concurrent radiotherapy Surgery: - See Disease Characteristics - Recovered from the effects of any prior major surgery Other: - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JuergenBecker, Study Chair, Universitaet Wuerzburg/Hautkrankheiten
Georg August Universitaet
Goettingen, , D-37075
Germany
Centre Hospital Regional Universitaire de Limoges
Limoges, , 87042
France
Haematologisch-Onkologische Praxis Altona
Hamburg, , D-22765
Germany
Universitaets - Augenklinik - Erlangen
Erlangen, , D-91054
Germany
Institut Jules Bordet
Brussels, , 1000
Belgium
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
CHU Ambroise Pare
Boulogne-Billancourt, , F-92104
France
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY
United Kingdom
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Erasmus University Medical Center
Rotterdam, , 3075 EA
Netherlands
Onkologicka Klinka A Onkologicka Lab
Prague, , 128 08
Czech Republic
Southend NHS Trust Hospital
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, , 1093
Portugal
Clinique Notre Dame de Grace
Gosselies, , 6041
Belgium
Institut Gustave Roussy
Villejuif, , F-94805
France
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Federal Armed Forces Hospital of Ulm - Department of Dermatology
Blaustein, , D-89134
Germany
Centre Eugene Marquis
Rennes, , 35042
France
UniversitaetsSpital
Zurich, , CH-8091
Switzerland
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
Christie Hospital N.H.S. Trust
Manchester, England, M20 9BX
United Kingdom
Krankenhaus der Elisabethinen
Linz, , 4020
Austria
Universitaet Wuerzburg/Hautkrankheiten
Wuerzburg, , D-97080
Germany
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
III Medizinische Klinik Mannheim
Mannheim, , D-68305
Germany
Universitaetsklinikum Benjamin Franklin
Berlin, , D-12200
Germany
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, , 33076
France
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Weston Park Hospital
Manchester, England, M20 9BX
United Kingdom
Eberhard Karls Universitaet
Tuebingen, , D-72076
Germany
Hopital L'Archet - 2
Nice, , F-06202
France
Additional Information:
Study ID Numbers: CDR0000068723; EORTC-18981
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020839
Other Recurrent Melanoma Studies:
1. Interferon gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors
2. Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
3. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
4. Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer Involving the Central Nervous System
5. CCI-779 in Treating Patients With Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Clinical Trials
Other Blaustein Clinical Trials
Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
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