AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors

RecruitingPhase 2Ages 18 Years - anyMaleN.N. Petrov National Medical Research Center of O…
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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).
💊

What it tests

  • High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )
📍

Where

1 site
National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy