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New treatment option for Germ Cell Tumor
Official title High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
ClinicalTrials.gov ID: NCT06418789
What this study is testing
What is High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )?
High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for germ cell tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patient is able to provide informed consent and sign approved consent forms to participate in the study.
- Males ≥ 18 years of age at the time of signing the IC Form.
- Histologically verified diagnosis of GO (seminomatous, non-seminomatous). 2\. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.))...
- Hemoglobin ≥ 90 g/L;
- neutrophils ≥ 1.5 x 109/L;
You likely can't join if
- Primary CS of the brain
- Administration of ≥2 lines of prior drug therapy for disseminated GO.
- Presence of active hepatitis B or hepatitis C, HIV infection, acute infectious disease, or activation of chronic infectious disease less than 28 days...
- Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).
See the full eligibility criteria
- Patient is able to provide informed consent and sign approved consent forms to participate in the study.
- Males ≥ 18 years of age at the time of signing the IC Form.
- 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...
- 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).
- Primary CS of the brain
- Administration of ≥2 lines of prior drug therapy for disseminated GO.
- 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.
- Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russian Federation, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russian Federation, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.