Teniposide plus cisplatin for newly diagnosed central malignant germ cell tumors
A Single-center, Single-arm, Open-label Study of the Combination of Teniposide Injection and Cisplatin in the Treatment of Newly Diagnosed Patients With Central Malignant Germ Cell Tumors.
This trial tests whether giving teniposide together with cisplatin helps people newly diagnosed with central malignant germ cell tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07188441 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm Phase 2 trial planning about 40 participants with newly diagnosed central malignant germ cell tumors. Participants receive teniposide 300 mg/m2 given IV over 3–5 days with 500 mL normal saline plus cisplatin 75 mg/m2 given IV over 3–5 days, repeated every 3 weeks for 4–6 cycles, with radiation therapy per standard practice after chemotherapy. The study monitors safety, anti-tumor activity, overall survival and performs drug monitoring to explore biomarkers that might predict response. Eligible patients must have at least one measurable lesion by RANO and adequate blood, liver and kidney function before enrollment.
Who should consider this trial
Good fit: Ideal candidates are people with a new diagnosis of central malignant germ cell tumor who have at least one measurable lesion, expected survival ≥6 months, and adequate blood counts, liver and kidney function who can give informed consent.
Not a fit: Patients with poor organ function, inadequate blood counts, pregnancy, inability to tolerate platinum or teniposide, or who have non-central germ cell tumors or extensive prior therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this regimen could extend overall survival and help identify which patients are most likely to benefit using biological predictive markers.
How similar studies have performed: Platinum-based chemotherapy is an established backbone for germ cell tumors, but the specific combination of teniposide plus cisplatin for central malignant germ cell tumors is less well studied and is relatively novel in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must have at least one measurable lesion defined by RANO criteria * The initial diagnosis has been confirmed as central malignant germ cell tumor * Expected survival period ≥ 6 months * Absolute neutrophil ≥1.0×10\^9/L; Platelet ≥100.0×10\^9/L * Aspertate aminotransferase and alanine aminotransferase ≤2.5×Upper limit of normal * total bilirubin ≤1.5×Upper limit of normal * Electronic Case Report of Form≥70mL/min/1.73m\^2 * Estimated glomerular filtration rate ≥ 70 mL/min/1.73 m² or normal serum creatinine (Cr) * Women and men with fertility must agree to use appropriate contraceptive methods (hormones or barrier therapy or abstinence) during the study period and within 3 months after the last dose; The pregnancy test of female subjects of childbearing age within 7 days before administration must be negative * Willing and able to read, understand, and sign written informed consent, parents/guardians of child or adolescent subjects have the ability to understand, agree, and sign research informed consent forms and applicable child consent forms before initiating any protocol related procedures Exclusion Criteria: * Patients undergoing any other anti-cancer experimental treatment * Individuals with a history of severe allergies or allergies to any component of the drugs in the past * Previous or concurrent active cardiovascular diseases with clinical significance, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valve disease, cardiomyopathy, and arrhythmia * Patients with Magnetic Resonance Imaging contraindications * Those who need to receive live virus vaccine during administration * Serious complications and/or underlying diseases * Individuals with poor control of hypertension (under standardized blood pressure reduction protocols, systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg) * Uncontrolled systemic bacterial, viral, or fungal infections * Patients infected with Human Immunodeficiency Virus(HIV) or syphilis * Patients who have undergone organ transplantation in the past * Pregnant or lactating women * Researchers believe that there are other factors that are not suitable for participating in the experiment
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: chengcheng Guo, Doctor of Medicine
- Email: guochch@sysucc.org.cn
- Phone: 020-87343890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.