Spots Global Cancer Trial Database for Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Official Title: TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
Study ID: NCT00002669
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
Detailed Description: OBJECTIVES: * Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2. * Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms. * Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses. Patients are followed every 2 months for 6 months, then every 3 months thereafter. PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Landeskrankenanstalten - Salzburg, Salzburg, , Austria
Institut Jules Bordet, Brussels (Bruxelles), , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
CHR de Besancon - Hopital Saint-Jacques, Besancon, , France
Centre Leon Berard, Lyon, , France
CHU Pitie-Salpetriere, Paris, , France
Universitaetsklinikum Charite, Berlin, , Germany
Universitaetsklinikum Benjamin Franklin, Berlin, , Germany
Robert Roessle Klinik, Berlin, , Germany
Haematologisch-Onkologische Praxis Altona, Hamburg, , Germany
Johannes Gutenberg University, Mainz, , Germany
III Medizinische Klinik Mannheim, Mannheim, , Germany
Istituto Europeo Di Oncologia, Milano, , Italy
University Medical Center Nijmegen, Nijmegen, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Instituto Portugues de Oncologia do Porto, Porto, , Portugal
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Universitaetsspital, Zurich, , Switzerland
St. James's Hospital, Leeds, England, United Kingdom
Royal Marsden NHS Trust, London, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Contact Details
Name: Ulrich Keilholz, MD
Affiliation: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
