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Brief Title: Trial of Nilotinib and Adriamycin as Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Official Title: GEIS-27: Phase I/II Multicenter and Prospective Trial of Nilotinib and Adriamycin as Neoadjuvant Treatment in Liposarcomas and Leiomyosarcomas of Retroperitoneum
Study ID: NCT02587169
Brief Summary: Phase I/II multicenter and prospective trial of nilotinib and adriamycin as neoadjuvant treatment in liposarcomas and leiomyosarcomas of retroperitoneum. The main objective of this study is to improve relapse-free survival (RFS)and overall survival (OS) decreasing from 50% to 30% the relapse percentage at 5 years in patients with resected sarcoma of retroperitoneum. Secondary objectives include the analysis of antitumoral activity through response rate (RECIST and tissular changes), the assessment of positive correlation between biomarkers and clinical results, the study of long term overall survival, and the analysis of the safety profile of the nilotinib-adriamycin combination. The trial hypothesis is that the nilotinib-adriamycin combination is synergistic and therefore better response results are expected (from 20% as P0 to 40% as P1). The study seeks to find a positive correlation between biomarkers and clinical results in retroperitoneal liposarcoma and leiomyosarcoma treated with the mentioned combination. The study involves the participation of 20 hospitals of the Spanish Sarcoma Group (GEIS). The treatment consists of 4 neoadjuvant cycles of nilotinib-adriamycin on patients with resectable retroperitoneal sarcoma. The research comprises a robust translational study as well as histological and radiological reviews.
Detailed Description: The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II). Phase I includes patients with retroperitoneal liposarcoma, retroperitoneal leiomyosarcoma and chondrosarcoma. Phase II is focused on retroperitoneal liposarcoma and leiomyosarcoma only.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Universitari Son Espases, Palma de Mallorca, Balearic Islands, Spain
Hospital Infanta Cristina, Badajoz, , Spain
Hospital Universitari Germans Trials i Pujol, Badalona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Provincial de Castellón, Castellón, , Spain
Hospital Universitario de Canarias, La Laguna, , Spain
Complejo Asistencial Universitario de León, León, , Spain
Hospital Puerta de Hierro, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Hospital Marqués de Valdecilla, Santander, , Spain
Hospital Clínico Universitario de Santiago, Santiago de Compostela, , Spain
Hospital Virgen del Rocío, Sevilla, , Spain
Hospital Virgen de la Salud, Toledo, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Xeral Cies, Vigo, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Name: Javier Martín, MD, PhD
Affiliation: Spanish Sarcoma Group (GEIS)
Role: STUDY_DIRECTOR