Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin for Treating Advanced Rare Tumors Including Pagets Disease of Scrotum, Rhabdomyosarcoma, Testicular, Penile, and Urachal Cancers

What this Trial Is About

Researchers are evaluating the combination of albumin-paclitaxel, ifosfamide, and cisplatin Nab-TIP in treating advanced rare tumors, including Pagets disease of the scrotum with infiltrating sweat gland carcinoma, rhabdomyosarcoma, testicular cancer, penile cancer, and urachal cancer. This single-arm phase II study aims to understand whether Nab-TIP improves the objective response rate and extends survival while assessing its safety in participants with these conditions. Participants will receive albumin-paclitaxel at a dose of 260 mgm2 on day 1, isocyclophosphamide 1500 mgm2 on days 2 to 5, and cisplatin 25 mgm2 on days 2 to 5. These treatments are given every 21 days for up to six cycles or until disease progression or intolerable side effects occur. The study includes a screening period before treatment, a treatment period, followed by a safety follow-up and a one-year survival follow-up with visits every three months. During the study, participants will undergo imaging evaluations every six weeks for the first year and every 12 weeks afterward to assess tumor response. Researchers will monitor and record any adverse events throughout the study, including their type, severity, and duration. After treatment ends, safety assessments continue with physical exams and lab tests, followed by regular survival follow-ups by telephone or visits, lasting until death, loss to follow-up, withdrawal, or study completion.

Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors