Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06418789

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

Led by N.N. Petrov National Medical Research Center of Oncology · Updated on 2025-08-03

25

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent and sign approved consent forms
  • Male patients 18 years of age or older at the time of consent
  • Histologically confirmed germ cell tumor (seminomatous or non-seminomatous)
  • Primary tumor located in gonadal or extragonadal sites (retroperitoneal, mediastinal, etc.)
  • Disease progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (BEP or EP)
  • Initial laboratory values meeting requirements: hemoglobin ≥ 90 g/L; neutrophils ≥ 1.5 x 10⁹/L; platelets ≥ 75 x 10⁹/L; creatinine within limits (≥ 1.5 x HGH or CKF ≤ 60 mL/min); ALT or AST ≤ 2.5 x HGN (≤ 5 x HGN if liver metastases present); bilirubin ≤ 1.5 x IUH (except Gilbert syndrome with total bilirubin ≤ 50 μmol/L); alkaline phosphatase ≤ 2.5 x IUH
  • No neurological symptoms if CNS metastases are present (asymptomatic CNS metastases allowed)
Not Eligible

You will not qualify if you...

  • Primary central nervous system tumor of the brain
  • Received two or more prior lines of drug therapy for disseminated germ cell tumor
  • Active hepatitis B or C, HIV infection, acute infection, or chronic infection activation within 28 days before study entry
  • Conditions limiting ability to follow study protocol such as psychiatric disorders or drug/alcohol dependence

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia

Saint Petersburg, Russian Federation, Russia, 197758

Actively Recruiting

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Research Team

A

Anna Semenova, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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