High-dose chemotherapy for relapsed germ cell tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the efficacy of high-dose chemotherapy as a second-line treatment for patients with relapsed germ cell tumors who have not responded to first-line platinum-based chemotherapy. The study involves administering two cycles of high-dose TI chemotherapy followed by three cycles of high-dose CE chemotherapy, culminating in autologous stem cell transplantation. The primary goal is to measure progression-free survival, while secondary endpoints include overall survival and safety assessments. Conducted at the N.N. Petrov National Medical Research Center of Oncology, this trial aims to address the unmet clinical need for effective salvage therapies in this patient population.

Why it matters

Who can join: the full rules

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).

Where it's running

• National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
  Saint Petersburg, Russian Federation, Russia Recruiting

Study contacts

• Study coordinator: Anna Semenova, MD, PhD
• Email: mirannia@yandex.ru
• Phone: 8 (812) 439-95-05

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Methionine-Reduced Diet in Solid Tumors (early-phase)

  A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.

  Recruiting Early Phase 1 University of California, Irvine · Orange, California · NCT07628634

• Teniposide plus cisplatin for newly diagnosed central malignant germ cell tumors

  This trial tests whether giving teniposide together with cisplatin helps people newly diagnosed with central malignant germ cell tumors.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07188441

• ZW251 for advanced liver, lung, and germ cell cancers

  This will test whether ZW251, an antibody-drug conjugate that targets GPC3, is safe and can shrink tumors in adults with advanced hepatocellular carcinoma, squamous cell non-small cell lung cancer, or germ cell tumors.

  Recruiting at 25 sites Phase 1 Zymeworks BC Inc. · San Francisco, California and 24 other locations · NCT07164313

• Maintenance zanzalintinib with oral etoposide after high-dose chemotherapy for germ cell tumor

  This treatment tests whether daily zanzalintinib together with cycles of oral etoposide can help people with relapsed or refractory germ cell tumors after high-dose chemotherapy and stem-cell transplant.

  Recruiting Phase 1/2 Indiana University · Indianapolis, Indiana · NCT06937866

• Low-dose aspirin to prevent venous blood clots during chemotherapy for advanced germ cell (testicular) cancer

  This trial will see if taking one daily low-dose aspirin (81 mg) during cisplatin chemotherapy prevents venous blood clots over six months in adults up to age 70 with high-risk advanced germ cell or testicular cancer.

  Recruiting at 3 sites Phase 2 Wake Forest University Health Sciences · Charlotte, North Carolina and 2 other locations · NCT06866964

• Creating a database for mediastinal tumors at Peking Union Medical College Hospital

  This study is creating a database to help doctors better understand and treat different types of mediastinal tumors by collecting information on their characteristics and imaging results.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT06421805

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.