Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor

Samsung Medical Center

Status and phase

Unknown

Phase 2

Conditions

Intracranial Non-germinomatous Germ Cell Tumor

Treatments

Drug: Etoposide

Drug: Carboplatin

Drug: Cyclophosphamide

Drug: Melphalan

Drug: Bleomycin

Radiation: Reduced dose radiotherapy

Drug: Thiotepa

Study type

Interventional

Funder types

Other

Identifiers

NCT02784054

2013-07-146

Details and patient eligibility

About

The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).

Full description

Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.

Enrollment

25 estimated patients

Sex

All

Ages

3 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.

Exclusion criteria

Patients with organ dysfunction (ejection fraction <40%, creatinine > 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase > 5 x ULN).
Pregnant or nursing women

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Intracranial NGGCT

Experimental group

Description:

1. Six cycles of chemotherapy with carboplatin, etoposide, bleomycin (CEB) and cyclophosphamide, etoposide, bleomycin (CyEB) regimen. 2. Peripheral blood stem cell collection during the first cycle of chemotherapy. 3. Surgery, if there is residual tumor after chemotherapy. 4. Tandem high dose chemotherapy (HDCT) and autologous stem cell transplantation (auto-SCT) * 1st HDCT: Carboplatin, thiotepa, etoposide * 2nd HDCT: Cyclophosphamide, melphalan 5. Reduced dose of radiotherapy