Treatment of rare advanced tumors with a combination of drugs

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

This study is testing a new combination of drugs to see if it can help people with rare advanced tumors live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06684327 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a drug combination consisting of albumin-paclitaxel, ifosfamide, and cisplatin (Nab-TIP) in patients with advanced rare tumors, including Paget's disease, rhabdomyosarcoma, testicular cancer, penile cancer, and urachal cancer. Participants will receive the treatment every 21 days for up to six cycles, with regular imaging assessments to monitor response and safety. The study aims to determine whether Nab-TIP can improve the objective response rate and prolong survival in these patients.

Who should consider this trial

Good fit: Ideal candidates include individuals with stage IV rare tumors such as Paget's disease of the scrotum, rhabdomyosarcoma, testicular cancer, penile cancer, or urachal cancer who meet specific health criteria.

Not a fit: Patients with early-stage tumors or those who do not have the specified types of cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with rare advanced tumors that currently have limited treatment options.

How similar studies have performed: While there have been studies on individual components of this treatment regimen, the specific combination of Nab-TIP for these rare tumors is novel and has not been extensively tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sheng Zhang, Doctor

Conditions Paget Disease, Extramammary; Rhabdomyosarcoma; Testicular Cancer; Penile Cancer; Urachal Cancer; rare tumor; albumin-paclitaxel; ifosfamide