RecruitingPhase 2NCT06684327

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

Sponsor

Fudan University

Enrollment

100 participants

Start Date

Nov 30, 2024

Study Type

INTERVENTIONAL

Conditions

Testicular Cancer Penile Cancer Urachal Cancer Paget Disease, Extramammary Rhabdomyosarcoma

Summary

The goal of this clinical trial is to learn if albumin-paclitaxel, ifosfamide and cisplatin (Nab-TIP) works to treat advanced rare tumors including PAGET's disease of scrotum with infiltrating sweat gland carcinoma （cohort 1）, rhabdomyosarcoma (cohort 2), testicular cancer (cohort 3), penile cancer (cohort 4), and urachus cancer (cohort 5) . It will also learn about the safety of Nab-TIP. The main questions it aims to answer are: Does Nab-TIP improve the objective response rate and prolong the survival of participants? What medical problems do participants have when receiving the regimen of Nab-TIP? Participants will: Receive albumin-paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, and cisplatin 25mg/m2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first. Be performed imaging evaluation according to RECIST 1.1 every 6 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy drugs (albumin-paclitaxel, ifosfamide, and cisplatin) in people with rare advanced cancers that have spread and have limited standard treatment options. **You may be eligible if...** - You have been diagnosed with one of these advanced (stage IV) rare cancers: Paget's disease of the scrotum, rhabdomyosarcoma, testicular cancer, penile cancer, or urachal cancer - Your cancer can be measured on a scan - You are physically functional enough to participate (ECOG 0–2) - Your blood counts, kidney, and liver function are in an acceptable range - You are expected to live at least 3 more months **You may NOT be eligible if...** - You have active or uncontrolled infections (including tuberculosis) - You have active hepatitis B or C, or HIV - You are on dialysis for kidney failure - You had major surgery or trauma in the past 4 weeks - You participated in another clinical trial in the past 4 weeks - You have a history of drug abuse or mental illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlbumin-paclitaxel Injection

Participant will receive albumin-paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, and cisplatin 25mg/m2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first.