Germ Cell TumorPhase 2GERMANNCT06418789
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
A Phase 2 study testing High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) in people with Germ Cell Tumor, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Germ Cell Tumor
- What is being tested?
- High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2024to 1 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 platinum-containing first-line chemotherapy (ВЕР or EP).
- 4. Required Initial Laboratory Values:
Show all 13Show fewer
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
Saint Petersburg, Russian Federation, 197758
Anna I Semenova, MD, PhD
About this study
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.
Read the detailed description
Germ cell tumors are curable diseases. Only a small proportion of patients fail to be cured: those who experience a primary resistance to chemotherapy and those who relapsed after first line conventional dose cisplatin-based chemotherapy. Nowadays, there is heterogeneity of practice in salvage approaches. This includes conventional chemotherapy high dose chemotherapy with autologous stem cell transplant. Best choice of the therapy strategy is an unmet clinical need now. This is why this single-center, non-randomized phase II study will be conducted at the N.N. Petrov National Medical Research Center of Oncology. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive two cycles of high-dose TI (Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest; leukapheresis will be performed starting on day 11 in case of CD45+CD34+ blood level above 20x10^6/L is achieved), followed by three cycles of high dose CE (Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m^2 IV daily days -4 to -2, autlologous stem cell transplantation at day 0, GCSF support from day 4.) The primary endpoint of the study is to evaluate the efficacy by measuring progression-free survival. The secondary endpoints of the trial are overall survival, response rate by RECIST, safety and prognostic factors analysis.
- Conditions
- Germ Cell Tumor
- Being tested
- High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )
- Keywords
- Germ Cell Tumor, Teratoma, Choriocarcinoma, Germinoma, Childhood Teratoma, Extragonadal Seminoma, Seminoma, Non-seminomatous Germ Cell Tumor, Yolk Sac Tumor, Mixed Germ Cell Tumor, Malignant Germ Cell Neoplasm
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Teratoma, Choriocarcinoma, Germinoma, Seminoma, Nonseminomatous germ cell tumor, Endodermal Sinus Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )Drug
TI: Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest. Leukapheresis will be performed starting on day 11 in case blood level of CD45+CD34+ above 20x10^6/L is achieved.
CE: Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m^2 IV daily days -4 to -2, autlologous stemm cell transplantation >=2*10^6/Kg at day 0, GCSF support from day 4 until the recovery of neutrophils above 1*10^9/L.
Patients will receive two cycles of TI followed by 3 cycles of CE in case at least 6*10^6 CD34+ stem cells will be harvested.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | In arm patients receive a TI-CE regime based on paclitaxel and ifosfamide in cycles 1-2 and carboplatin and etoposide in cycles 3-5. Receives: Drug: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression Free Survival 2-year
Measured: Up to 24 months post-treatment
Secondary outcomes (7)
Overall survival (OS)
Overall survival (OS) 3-year
Measured: Up to 36 months post-treatment
Incidence of adverse events
All toxicities will be evaluated and recorded based on the NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Measured: Up to 3 months post-therapy discontinuation
Validation of International Prognostic Factor Study Group stratification system
Evaluation of the efficacy of high-dose TI (2 cycles)-CE (3 cycles) chemotherapy in patients with germ cell tumors of gonadal and extragonadal localization who progressed after prior platinum-containing first-line chemotherapy and received high-dose TI (2 cycles)-CE (3 cycles) chemotherapy, depending on the prognosis group (IGCCCG classification (1997), IGCCCG Update Model (2021)).
Measured: Up to 3 years post-registration
Assessment of patients' quality of life
European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Measured: also during the 5-year follow-up period.
Possibilities of rehabilitation
Evaluation of the impact of patient nutritional support and the relationship between patient nutrition and the incidence of non-hematologic complications (mucositis, colitis, infectious complications)
Measured: also during the 5-year follow-up period.
Assessment of the possibility of improving mobilization rates with the drug "Plerixafor"
In case of poor mobilization according to the criteria of the European Society of Bone Marrow Transplantation, the addition of Plerixafor at a dose of 24 mg to the mobilization is envisaged.
An evaluation of the feasibility of improving mobilization rates with Plerixafor is planned.
Measured: 2 months
Response Rate
Incidence of complete, partial response, stable and progressive disease by RECIST 1.1 system
Measured: Every 8 weeks up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Igorevna Semenova, N.N. Petrov National Medical Research Center of Oncology
- Investigators
- Aleksei M Belyaev, MD,DSc,Prof., Study director, National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of RussiaTatyana Yu Semiglazova, MD,DSc,Prof., Study chair, National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418789
- Sponsor's protocol ID
- German2
- Acronym
- GERMAN
- Status last verified
- Jul 2025
- First submitted
- 8 May 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
- ClinicalTrials.gov ID
- NCT06418789
- Acronym / sponsor ID
- GERMAN / German2
- Conditions
- Germ Cell Tumor
- Keywords
- Germ Cell Tumor, Teratoma, Choriocarcinoma, Germinoma, Childhood Teratoma, Extragonadal Seminoma, Seminoma, Non-seminomatous Germ Cell Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Germ cell tumors are curable diseases. Only a small proportion of patients fail to be cured: those who experience a primary resistance to chemotherapy and those who relapsed after first line conventional dose cisplatin-based chemotherapy. Nowadays, there is heterogeneity of practice in salvage approaches. This includes conventional chemotherapy high dose chemotherapy with autologous stem cell transplant. Best choice of the therapy strategy is an unmet clinical need now. This is why this single-center, non-randomized phase II study will be conducted at the N.N. Petrov National Medical Research Center of Oncology. Patients with germ cell tumors of gonadal and extragonadal localization who have progressed after prior platinum-containing first-line chemotherapy will receive two cycles of high-dose TI (Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest; leukapheresis will be performed starting on day 11 in case of CD45+CD34+ blood level above 20x10^6/L is achieved), followed by three cycles of high dose CE (Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m^2 IV daily days -4 to -2, autlologous stem cell transplantation at day 0, GCSF support from day 4.) The primary endpoint of the study is to evaluate the efficacy by measuring progression-free survival. The secondary endpoints of the trial are overall survival, response rate by RECIST, safety and prognostic factors analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )In arm patients receive a TI-CE regime based on paclitaxel and ifosfamide in cycles 1-2 and carboplatin and etoposide in cycles 3-5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 platinum-containing first-line chemotherapy (ВЕР or EP).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )TI: Paclitaxel 200mg/m² on day 1, Ifosfamide 2000mg/m² daily from days 1 to 3 of 14-day cycle. G-CSF 10 micrograms/Kg SC daily day on days 6-14 day or until CD34 harvest. Leukapheresis will be performed starting on day 11 in case blood level of CD45+CD34+ above 20x10^6/L is achieved. CE: Carboplatin AUC=8 IV daily days -4 to -2, Etoposide 400mg/m^2 IV daily days -4 to -2, autlologous stemm cell transplantation >=2*10^6/Kg at day 0, GCSF support from day 4 until the recovery of neutrophils above 1*10^9/L. Patients will receive two cycles of TI followed by 3 cycles of CE in case at least 6*10^6 CD34+ stem cells will be harvested. | Drug | Group 1 |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 24 months post-treatment
Progression Free Survival 2-year
7 secondary outcomes
Overall survival (OS)
Time frame: Up to 36 months post-treatment
Incidence of adverse events
Time frame: Up to 3 months post-therapy discontinuation
Validation of International Prognostic Factor Study Group stratification system
Time frame: Up to 3 years post-registration
Assessment of patients' quality of life
Time frame: also during the 5-year follow-up period.
Possibilities of rehabilitation
Time frame: also during the 5-year follow-up period.
Assessment of the possibility of improving mobilization rates with the drug "Plerixafor"
Time frame: 2 months
Response Rate
Time frame: Every 8 weeks up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksei M Belyaev, MD,DSc,Prof. study director
National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
Tatyana Yu Semiglazova, MD,DSc,Prof. study chair
National Medical Research Center of Oncology named after N.N.Petrov Ministry of health of Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles ) in people with Germ Cell Tumor, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Semenova, MD, PhD (8 (812) 439-95-05, mirannia@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 24 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.