Actively Recruiting
Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin for Treating Rare Advanced Tumors including Paget's Disease, Rhabdomyosarcoma, Testicular, Penile, and Urachal Cancers
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
Researchers are evaluating the safety and effectiveness of a combination chemotherapy regimen called Nab-TIP, which includes albumin-paclitaxel, ifosfamide, and cisplatin, in treating several advanced rare tumors. These tumors include Paget's disease of the scrotum with infiltrating sweat gland carcinoma, rhabdomyosarcoma, testicular cancer, penile cancer, and urachal cancer. This is a phase II, single-arm study aiming to assess whether Nab-TIP can improve the objective response rate and prolong survival in participants with these cancers. Participants 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. This treatment cycle repeats 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 with chemotherapy cycles, and a follow-up phase. Throughout the study, participants undergo imaging evaluations every six weeks during the first year and every 12 weeks thereafter to monitor tumor response. Adverse events are recorded according to standard criteria to track safety. After treatment ends, there is a safety follow-up visit around 30 days later, followed by survival follow-up every three months for up to one year or until death, loss to follow-up, or withdrawal. Researchers measure the objective response rate at 12 weeks as the primary outcome.
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
Eligibility Criteria
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
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
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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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