Clinical Research Directory

Organoid Drug Sensitivity-Guided Therapy for Refractory Tumors

This multicenter study will evaluate whether patient-derived tumor organoid drug sensitivity testing can help guide treatment selection for adults with refractory, unresectable, or metastatic tumors after standard treatment options have been exhausted. Fresh tumor tissue or malignant effusion will be collected when clinically obtained, and patient-derived organoids (PDOs) will be established and tested against clinically available drugs. Participants with successful organoid establishment and drug sensitivity results will receive treatment selected with reference to the test results and multidisciplinary clinical judgment. Tumor response will be assessed using RECIST version 1.1, with follow-up for progression, survival, and safety. The study plans nine tumor-specific cohorts.

Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.