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

Launched by FUDAN UNIVERSITY · Nov 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination called Nab-TIP, which includes albumin-paclitaxel, ifosfamide, and cisplatin. The goal is to see if this treatment can help people with rare advanced tumors, such as Paget's disease of the scrotum, rhabdomyosarcoma, testicular cancer, penile cancer, and urachal cancer. Researchers want to find out if Nab-TIP can improve treatment outcomes and extend survival while also monitoring any side effects that participants may experience.

To participate in this trial, individuals must have a confirmed diagnosis of one of the specified cancers, be at Stage IV of the disease, and have a good performance status, meaning they can carry out everyday activities without major assistance. Participants should be expected to live for at least three more months and have measurable disease that can be seen on imaging tests. Throughout the study, participants will receive treatment every 21 days and will undergo regular check-ins to monitor their health and any side effects. This trial is currently recruiting patients, and it’s important for interested individuals to talk to their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Individuals able to understand and give written informed consent.
• * Histologically or cytologically confirmed cancer of one of the following types:
• • PAGET's disease of scrotum with infiltrating sweat gland carcinoma Rhabdomyosarcoma Testicular cancer Penile cancer Urachal cancer
• • Stage IV disease
• • Adequate performance status (ECOG 0-2)
• • Expected survival ≥ 3 months.
• • Measurable disease by CT or MRI, Or lesions with skin infiltration.
• • Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3).
• • Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
• • Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
• • Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.
• • Ability to comply with research visit schedules and other protocol requirements.
• Exclusion Criteria:
• • 1. Active or uncontrolled severe infections (≥CTCAE Level 2) requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infections.
• • 2. Active hepatitis (transaminases not within inclusion criteria; HBV reference: HBV DNA ≥2000 IU/ml or ≥10\^4 copies/ml; HCV reference: HCV RNA ≥2000 IU/ml or ≥10\^4 copies/ml; after nucleoside antiviral treatment below the above standards, may be eligible; chronic HBV carrier with HBV DNA \<10\^4 IU/ml, must receive antiviral treatment during the study period to be eligible).
• • 3. Renal failure requiring hemodialysis or peritoneal dialysis.
• • 4. History of immunodeficiency, including HIV positive or having other acquired/congenital immunodeficiency diseases, or organ transplant history.
• • 5. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness, and constipation.
• • 6. History of active tuberculosis.
• • 7. Uncontrolled ascites, pleural effusion, or pericardial effusion requiring repeated drainage.
• • 8. Patients who have undergone major organ transplantation.
• • 9. Individuals who have undergone major surgical procedures, open biopsies, or obvious traumatic injuries within 28 days prior to the start of the study; or have unhealed wounds or fractures for a long time;
• • 10. Individuals who have participated or are currently participating in another clinical study within the past 4 weeks prior to the start of the study;
• • 11. Individuals with a history of severe allergies;
• • 12. Individuals at risk of bleeding, or with impaired coagulation function, or who are currently receiving thrombolytic therapy;
• • 13. Individuals with a history of substance abuse with no ability to abstain or with a mental disorder.
• • 14. According to the investigator's judgment, subjects with serious adverse effects on their safety or completion of the study, or those with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or those with other reasons deemed unsuitable for enrollment by the investigator. Subjects with a history of a clearly defined neurological or psychiatric disorder, such as dementia, epilepsy, or a history of epilepsy prone.