Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06684327

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

Led by Fudan University · Updated on 2024-12-20

100

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and provide written informed consent
  • Histologically or cytologically confirmed diagnosis of one of the following cancers: Paget's disease of scrotum with infiltrating sweat gland carcinoma, rhabdomyosarcoma, testicular cancer, penile cancer, or urachal cancer
  • Stage IV disease
  • Adequate performance status with ECOG score between 0 and 2
  • Expected survival of at least 3 months
  • Measurable disease by CT or MRI, or lesions with skin infiltration
  • Adequate blood counts without ongoing transfusion support (hemoglobin > 9 g/dL, ANC > 1500/mm3, platelets > 100,000/mm3)
  • Adequate kidney and liver function within specified laboratory limits
  • Adequate coagulation function (INR ≤ 1.5, PT ≤ 1.5×ULN, aPTT ≤ 1.5×ULN)
  • Willing to use medically approved contraception from enrollment until at least 120 days after study end
  • Able to comply with research visit schedules and protocol requirements
Not Eligible

You will not qualify if you...

  • Active or uncontrolled severe infections requiring systemic antibacterial, antifungal, or antiviral therapy including tuberculosis
  • Active hepatitis with transaminases outside inclusion limits or high viral loads of HBV or HCV without effective antiviral treatment
  • Renal failure requiring dialysis
  • History of immunodeficiency including HIV or organ transplantation
  • Severe symptoms such as nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness, or constipation
  • History of active tuberculosis
  • Uncontrolled ascites, pleural effusion, or pericardial effusion needing repeated drainage
  • Major organ transplantation recipients
  • Major surgery, open biopsies, or traumatic injuries within 28 days prior to study start, or unhealed wounds or fractures
  • Participation in another clinical trial within 4 weeks before starting this study
  • History of severe allergies
  • Risk of bleeding, impaired coagulation, or current thrombolytic therapy
  • History of substance abuse without ability to abstain or mental disorder
  • Serious adverse health conditions or neurological/psychiatric disorders judged by investigator to affect safety or study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

S

Sheng Zhang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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