NCT06418789 High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
| NCT ID | NCT06418789 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology |
| Condition | Germ Cell Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-03-01 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, single-center, non-randomized phase II study. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive high-dose chemotherapy with TI (2 cycles) folollowed by high dose CE chemotherapy with autologous stem cell transplantation (3 cycles). The primary endpoint of the study is to evaluate the efficacy high-dose chemotherapy as second-line drug therapy for patients with advanced germ cell tumors.
Eligibility Criteria
Inclusion Criteria: 1. Patient is able to provide informed consent and sign approved consent forms to participate in the study. 2. Males ≥ 18 years of age at the time of signing the IC Form. 3. Histologically verified diagnosis of GO (seminomatous, non-seminomatous). 2\. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO. 3\. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP). 4\. Required Initial Laboratory Values: * Hemoglobin ≥ 90 g/L; * neutrophils ≥ 1.5 x 109/L; * platelets ≥ 75 x 109/L; * creatinine ≥ 1.5 x HGH (or CKF ≤ 60 mL/min); * ALT or AST ≥ 2.5 x HGN (5 x HGN for patients with liver metastases); * bilirubin ≥ 1.5 x IUH (except for patients with Gilbert syndrome, in whom total bilirubin levels should not exceed 50 μmol/L); * alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presence of CNS metastases (asymptomatic CNS metastases are acceptable). Exclusion Criteria: 1. Primary CS of the brain 2. Administration of ≥2 lines of prior drug therapy for disseminated GO. 3. Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days prior to study inclusion. 4. Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).
Contact & Investigator
Aleksei M Belyaev, MD,DSc,Prof.
STUDY DIRECTOR
National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
Frequently Asked Questions
Who can join the NCT06418789 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Germ Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06418789 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06418789 currently recruiting?
Yes, NCT06418789 is actively recruiting participants. Contact the research team at mirannia@yandex.ru for enrollment information.
Where is the NCT06418789 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06418789 clinical trial?
NCT06418789 is sponsored by N.N. Petrov National Medical Research Center of Oncology. The principal investigator is Aleksei M Belyaev, MD,DSc,Prof. at National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia. The trial plans to enroll 25 participants.