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

Recruiting Phase 2 Interventional Study
Germ Cell Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
N.N. Petrov National Medical Research Center of Oncology · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient is able to provide informed consent and sign approved consent forms to participate 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). 2\. Any (gonadal and extragona…
Contacts

Anna Semenova, MD, PhD

8 (812) 439-95-05

mirannia@yandex.ru

CONTACT