Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Endodermal Sinus Tumor

Teratoma

Germinoma

Carcinoma, Embryonal

Choriocarcinoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Trophoblastic Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Germ Cells Tumors

Central Nervous System Germinoma

Embryonal Carcinoma

Testicular Yolk Sac Tumor

Children and adolescents with a germ cell tumor, previously enrolled on APEC14B1 or AEPI10N1 who allow access to medical records (including audiograms), grant permission to: evaluate of all of their DNA, place their genetic and health information in scientific databanks, and collect a blood sample at a routine clinic/home visit, as well as complete a questionnaire about your health and quality of life since treatment.

Questionnaire provide to participant's about their health and quality of life since treatment

Questionnaire Administration

Tumor DNA requested from the Biopathology Center

Tumor Specimen Collection

Germline DNA specimens requested from the Biopathology Center or newly collected saliva

Germline DNA Samples

Blood Sample Collection

Jenny Poynter, PhD

A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.

PRIMARY OBJECTIVES:

I. Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment.

II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.

III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death.

OUTLINE:

Medical records from pediatric and adolescent Germ Cell Tumor (GCT) participants from AEPI10N1 and APEC14B1 will be used to obtain treatment information and validate self-reported outcomes. Paired normal and tumor samples will be used to evaluate single nucleotide variants, indels, copy number variations, and DNA methylation patterns. Ototoxicity will be determined by central review of audiogram files obtained from the treating institutions and self-reported based on questionnaire data.

* Tumor Specimen Collection
* Germline DNA Samples (saliva)
* Blood Sample Collection (serum/plasma)

Molecular Epidemiology of Pediatric Germ Cell Tumors

Pediatric Germ Cell Tumors: Outcomes, Genomics and Epigenetics

Ototoxicity as determined by central review of end of therapy audiograms will serve as the primary outcome variable for analyses. Current ototoxicity will be assessed using an app-based hearing assessment. For the app-based audiometry assessment, unilateral hearing loss will be defined as at least one pure tone threshold greater than 25 decibels across at any one of the frequencies from 2,000 Hz- 8,000 Hz to align with the SIOP Boston guidelines, while bilateral hearing loss will be defined as a pure tone threshold \> 25 decibels in both ears at any one of the frequencies.

Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification. Somatic mutations will be identified by comparing tumor samples to normal samples. Risk stratification will be based on event free survival, defined as the time from diagnosis to relapse or death.

Compare the association between DNA methylation patterns and relapse or death. Mixed-effects regression models will be used to test for association between methylation beta values and poor outcomes. The outcome will be defined as a binary variable with a value of one if the patient experienced a relapse or death event and zero otherwise.

Children's Oncology Group

Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Extragonadal Germ Cell Tumor

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

cisplatin

etoposide

conventional surgery

neoadjuvant therapy

radiation therapy

Jan C. Buckner, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and etoposide in treating patients with CNS tumors.

OBJECTIVES:

* Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide.
* Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy.
* Determine endocrine and cognitive function in these patients before and after receiving this regimen.

OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma).

Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses, if feasible, and then proceed to radiotherapy. Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy.

Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on histology, extent of disease, and response to chemotherapy. Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 years.

Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors

Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies

National Cancer Institute (NCI)

Mayo Clinic

Jan C. Buckner , MD

Paclitaxel

Albumin-Bound Paclitaxel

Ifosfamide

Isophosphamide mustard

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Paclitaxel 240mg/m2/day D1 (total 240mg/m2) Ifosfamide 1.5g/m2/day D2\~5 (total 6g/m2) Cisplatin 25mg/m2/day D2\~5 (total 100mg/m2)

TIP treatment (paclitaxel/ifosfamide/cisplatin)

Jung Woo Han

Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy. Especially more than 11 years old, mediastinal germ cell tumor, stage 3 or 4 extragonodal germ cell tumor or the remained tumor after the primary treatment are the group with the poorest prognosis.

Paclitaxel is widely used chemotherapeutic agent in adults and the experience of the agent has also been accumulated in children. The paclitaxel, ifosfamide, cisplatin (TIP) regimen has been used 2nd-line treatment for germ cell tumor and there is some promising result of the role of TIP in first line germ cell tumor treatment. In high risk pediatric germ cell tumor patients, TIP regimen will be able to reduce lung toxicity from the bleomycin as the standard regimen and to improve the survival. In this trial, the efficacy and safety of TIP as the first line treatment for germ cell tumor will be elucidated.

Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor

Non-randomized, Phase II, Open-label Study for Efficacy and Safety of Consolidation Paclitaxel/Ifosfamide/Cisplatin (TIP) Chemotherapy for High Risk Pediatric Germ Cell Tumor

Yonsei University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Epidemiology of Pediatric Germ Cell Tumors	NCT05564026	Germ Cell Tumor Germinoma Teratoma Embryonal Carci... Yolk Sac Tumor Choriocarcinoma Mixed Germ Cell... Late Effects Pediatric Germ ...	Questionnaire A... Tumor Specimen ... Germline DNA Sa... Blood Sample Co...	-	Children's Oncology Group
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors	NCT00002472	Brain and Centr... Pediatric Germ ... Extragonadal Ge...	cisplatin etoposide conventional su... neoadjuvant the... radiation thera...	3 Years -	Mayo Clinic
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors	NCT00002472	Brain and Centr... Pediatric Germ ... Extragonadal Ge...	cisplatin etoposide conventional su... neoadjuvant the... radiation thera...	3 Years -	Mayo Clinic
Molecular Epidemiology of Pediatric Germ Cell Tumors	NCT05564026	Germ Cell Tumor Germinoma Teratoma Embryonal Carci... Yolk Sac Tumor Choriocarcinoma Mixed Germ Cell... Late Effects Pediatric Germ ...	Questionnaire A... Tumor Specimen ... Germline DNA Sa... Blood Sample Co...	-	Children's Oncology Group
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor	NCT05455918	Pediatric Germ ...	TIP treatment (...	1 Year - 20 Years	Yonsei University

Spots Global Cancer Trial Database for pediatric germ cell tumor