Treatment Name: Phase II Study of Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiotherapy With or Without Peripheral Blood Stem Cell Rescue in Patients With Intracranial

Non-Germinomatous Germ Cell Tumors

Keywords: Stem cell transplant
Phase: Phase 2
Treatment ID#s: VT619 NCT00047320
Age Group: Adult and Pediatric
Min Karnofsky Score: 10: Fatal processes progressing rapidly
Conditions: Newly Diagnosed: Y
Recurrent: Y

Prior Surgery is Allowed
Prior Radiation is Not Allowed
Prior Chemotherapy is Not Allowed
Tumor Types: Germ Cell Tumors

Comments: This is a multi-institutional clinical research study which is aimed at improving disease-free and overall survival for patients diagnosed with a non-germinoma germ cell tumor (NGGCT), a malignant brain tumor formed by cancerous germ cells, by using multi-agent chemotherapy followed by radiotherapy. Patients will initially receive four 3-week chemotherapy cycles utilizing a three-drug regimen consisting of Cisplatin, Etoposide and Ifosfamide. If the patient has a complete response (CR), i.e., complete disappearance of the tumor after these 4 cycles, they will then proceed to radiation therapy. If there is still residual disease after 4 cycles of the initial chemotherapy, a second look surgery may be considered. If second surgery is performed and there is no detectable residual disease, the patient will receive radiation therapy. If there is residual tumor detected either by an MRI scan or the presence of raised tumor markers in the blood or cerebrospinal fluid after chemotherapy and second surgery (when performed), the patient will receive an additional regimen of two cycles of dose-intensified chemotherapy (Cyclophosphamide and Carboplatin) administered with the support of healthy peripheral blood stem cells.

Treatment Type: Chemotherapy

Rhode Island Hospital
Sam W. Lew, MD
Providence, RI 02903
Phone: 401-444-5171