A Phase II Trial Evaluating Chemotherapy followed by Response-Based Reduced Radiation Therapy for Patients with Central Nervous System Germinomas
Contact:
NCT Number:
Protocol:
AAAV8360
Study Status:
Active/Enrolling
Population:
Pediatrics/Adult
Phase:
II
The purpose of the study is to see how well a lower dose radiotherapy after chemotherapy treats children with central nervous system germinomas. The primary objective is to determine whether 12 Gy whole ventricular irradiation (WVI) and 12 Gy tumor boost would maintain similar efficacy compared to ACNS1123 stratum 2 as measured by event-free survival (EFS) in eligible patients with localized primary central nervous system (CNS) germinoma who present with serum and/or CSF human chorionic gonadotropin-beta (hCGβ) ≤ 100 IU/L and normal AFP, and meet complete response (CR) or continued complete response (CCR) criteria following chemotherapy/second-look surgery (Stratum 1).
Are you Eligible? (Inclusion Criteria)
- Age: Patients must be ≥ 3 years and < 30 years at the time of enrollment on screening. -Diagnosis: Patients suspected of having newly diagnosed primary localized germinoma of the suprasellar and/or pineal region; germinoma of the basal ganglia and or/thalamic primary sites; metastatic germinoma are eligible. -Consent: Patient and/or their parents or legal guardians have signed informed consent for APEC14B1 Part A – Eligibility Screening.
Specialty Area(s)
Childhood and Adolescent Cancers (Pediatric)
Principal Investigator
Trial Location(s)
CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032

