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

NCT06418789 | Recruiting Phase 2

• 1 other identifier: German2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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

Germ Cell Tumor

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression Free Survival 2-year

  Up to 24 months post-treatment

Secondary Outcomes (7)

• Overall survival (OS)

  Up to 36 months post-treatment

• Incidence of adverse events

  Up to 3 months post-therapy discontinuation

• Validation of International Prognostic Factor Study Group stratification system

  Up to 3 years post-registration

• Assessment of patients' quality of life

  also during the 5-year follow-up period.

• Possibilities of rehabilitation

  also during the 5-year follow-up period.

Study Arms (1)

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.

Drug: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization of primary GO.
• \. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕР or EP).
• \. 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).

You may not qualify if:

• Primary CS of the brain
• Administration of ≥2 lines of prior drug therapy for disseminated GO.
• Conditions that limit the patient's ability to fulfill the requirements of the protocol (psychiatric disorders, drug or alcohol dependence).

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

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

Saint Petersburg, Russian Federation, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Teratoma; Choriocarcinoma; Germinoma; Seminoma; Nonseminomatous germ cell tumor; Endodermal Sinus Tumor

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Trophoblastic Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mesonephroma

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Aleksei M Belyaev, MD,DSc,Prof.

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

  STUDY DIRECTOR

• Tatyana Yu Semiglazova, MD,DSc,Prof.

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

  STUDY CHAIR

Central Study Contacts

Anna Semenova, MD, PhD

CONTACT

8 (812) 439-95-05; mirannia@yandex.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical oncologist

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 17, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)