Actively Recruiting
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of albumin-paclitaxel, ifosfamide, and cisplatin (Nab-TIP) in treating advanced rare tumors, including Paget's 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 mg/m2 on day 1, isocyclophosphamide 1500 mg/m2 on days 2 to 5, and cisplatin 25 mg/m2 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.
CONDITIONS
Brief Title
Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written informed consent
- Histologically or cytologically confirmed diagnosis of Paget's disease of scrotum with infiltrating sweat gland carcinoma, rhabdomyosarcoma, testicular cancer, penile cancer, or urachal cancer
- Stage IV disease
- Performance status of 0 to 2 on the ECOG scale
- Expected survival of at least 3 months
- Measurable disease by CT or MRI, or lesions with skin infiltration
- Adequate blood counts without need for ongoing transfusions (hemoglobin > 9 g/dL, ANC > 1500/mm3, platelets > 100,000/mm3)
- Adequate kidney and liver function within defined limits
- Adequate blood clotting function (INR ≤ 1.5, PT ≤ 1.5 x ULN, aPTT ≤ 1.5 x ULN)
- Willing to use medically approved contraception during and for 120 days after the study
- Able to comply with study visit schedules and protocol requirements
You will not qualify if you...
- Active or uncontrolled severe infections requiring systemic therapy
- Active hepatitis or uncontrolled viral hepatitis infections
- Kidney failure requiring dialysis
- History of immunodeficiency, including HIV or organ transplant
- Severe symptoms such as nausea, headache, insomnia, fatigue, dizziness, or constipation
- History of active tuberculosis
- Uncontrolled fluid buildup requiring repeated drainage
- Major organ transplant recipients
- Recent major surgery, open biopsies, traumatic injuries, or unhealed wounds within 28 days
- Participation in another clinical trial within 4 weeks prior to this study
- History of severe allergies
- Risk of bleeding, impaired clotting, or current clot-dissolving therapy
- History of substance abuse or mental disorders impacting participation
- Serious conditions or diseases that may endanger safety or study completion as judged by the investigator
- History of neurological or psychiatric disorders such as dementia or epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days before first treatment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 weeks (6 cycles every 3 weeks)
Participants receive albumin-paclitaxel, ifosfamide, and cisplatin chemotherapy every 3 weeks for up to 6 cycles or until disease progression or intolerable side effects.
6 treatment visits every 3 weeks
Duration - Approximately 1 year after safety follow-up
Participants are followed for safety 30 days after last treatment, then survival follow-up every 3 months for up to 1 year or until death, withdrawal, or loss to follow-up.
1 safety follow-up visit and quarterly survival follow-ups (may be by phone)
Trial Site Locations
Total: 1 location
1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Sheng Zhang, Doctor
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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