Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate high-dose chemotherapy as a second-line drug therapy for patients with advanced germ cell tumors who have not responded to prior platinum-containing first-line chemotherapy. The study focuses on patients with germ cell tumors located in gonadal and extragonadal areas, addressing the unmet need for optimal salvage treatment strategies in this group. It is a prospective, single-center, non-randomized phase II trial designed to assess treatment efficacy and safety. Participants will receive two cycles of high-dose TI chemotherapy, which includes paclitaxel and ifosfamide, followed by three cycles of high-dose CE chemotherapy consisting of carboplatin and etoposide. Autologous stem cell transplantation will be performed after CE cycles. Growth factor support and leukapheresis will be used to collect stem cells if certain blood cell levels are achieved. The treatment cycles are carefully timed and supported by medications to aid recovery. Throughout the study, patients will undergo regular assessments including imaging to evaluate tumor response, laboratory tests to monitor blood counts and organ function, and quality of life evaluations. Researchers will measure progression-free survival as the primary outcome over 24 months, with additional monitoring of overall survival, adverse events, and prognostic factors up to several years post-treatment. Rehabilitation possibilities and stem cell mobilization improvements will also be assessed, with long-term follow-up over five years.
CONDITIONS
Brief Title
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Male aged 18 years or older
- Histologically confirmed diagnosis of gonadal or extragonadal germ cell tumor
- Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy
- Hemoglobin level at least 90 g/L
- Neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 75 x 10^9/L
- Creatinine clearance of at least 60 mL/min or creatinine not exceeding 1.5 times the upper normal limit
- ALT or AST not exceeding 2.5 times the upper normal limit (5 times if liver metastases present)
- Bilirubin not exceeding 1.5 times the upper normal limit (or total bilirubin level under 50 µmol/L for patients with Gilbert syndrome)
- Alkaline phosphatase not exceeding 2.5 times the upper normal limit
- No neurological symptoms if CNS metastases are present (asymptomatic CNS metastases allowed)
You will not qualify if you...
- Primary central nervous system tumor of the brain
- Received two or more prior drug therapies for disseminated germ cell tumor
- Active hepatitis B or C infection, HIV infection, or acute infectious disease within 28 days before study entry
- Psychiatric disorders or drug/alcohol dependence limiting protocol compliance
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 weeks
Participants receive two cycles of high-dose TI chemotherapy followed by three cycles of high-dose CE chemotherapy with autologous stem cell transplantation.
Multiple visits over treatment cycles including leukapheresis and transplant days
Duration - Up to 5 years
Participants are monitored for progression-free survival, overall survival, adverse events, quality of life, rehabilitation, and response rate after treatment completion.
Regular visits with assessments approximately every 8 weeks for 6 months, then longer-term follow-up visits
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
Research Team
A
Anna Semenova, MD, PhD
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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