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

Last updated: May 13, 2024
Sponsor: N.N. Petrov National Medical Research Center of Oncology
Overall Status: Active - Recruiting

Phase

2

Condition

Genitourinary Cancer

Brain Tumor

Testicular Cancer

Treatment

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

Clinical Study ID

NCT06418789
German2
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is able to provide informed consent and sign approved consent forms toparticipate 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).

  4. Any (gonadal and extragonadal (retroperitoneal, mediastinal, etc.)) localization ofprimary GO.

  5. Progression after 3 or 4 cycles of platinum-containing first-line chemotherapy (ВЕРor EP).

  6. 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 totalbilirubin levels should not exceed 50 μmol/L);

  • alkaline phosphatase ≥ 2.5 x IUH. 5. Absence of neurologic symptoms in the presenceof CNS metastases (asymptomatic CNS metastases are acceptable).

Exclusion

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 infectiousdisease, or activation of chronic infectious disease less than 28 days prior tostudy inclusion.

  4. Conditions that limit the patient's ability to fulfill the requirements of theprotocol (psychiatric disorders, drug or alcohol dependence).

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: High-dose chemotherapy (TI- 2 cycles, CE- 3 cycles )
Phase: 2
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2029

Study 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.

Connect with a study center

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

    Saint Petersburg, 197758
    Russian Federation

    Active - Recruiting

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