High-dose chemotherapy for relapsed germ cell tumors

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

This study is testing if high-dose chemotherapy can help people with relapsed germ cell tumors who didn't respond to their first treatment feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: N.N. Petrov National Medical Research Center of Oncology (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Saint Petersburg, Russian Federation)
• Trial ID: NCT06418789 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 and older with histologically verified germ cell tumors who have progressed after platinum-based chemotherapy.

Not a fit: Patients with non-germ cell tumors or those who have not received prior platinum-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced germ cell tumors who have relapsed after initial therapy.

How similar studies have performed: Previous studies have shown promise with high-dose chemotherapy approaches in similar patient populations, indicating potential for success in this trial.

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).

Where this trial is running

Saint Petersburg, Russian Federation

• 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

Conditions Germ Cell Tumor; Teratoma; Choriocarcinoma; Germinoma; Childhood Teratoma; Extragonadal Seminoma; Seminoma; Non-seminomatous Germ Cell Tumor