Clinical Trial: Cancer

ACNS1123 Localized Central Nervous System Germ Cell Tumors (PRO00003711)

Full Name

ACNS1123:  Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors. 

Description

If you agree to participate in this research study and your localized primary central nervous system tumor is a non-germinomatous germ cell tumor (NGGCT), you will receive induction therapy comprising of carboplatin IV over 15-60 minutes on day 1 and etoposide IV over1-2 hours on days 1-3 of courses 1, 3 and 5.  You will also receive ifosfamide IV over 1 hour and etoposide over 1-2 hours on days 1-5 of courses 2, 4 and 6.  Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.  Patients with responsive disease (complete response [CR] or partial response [PR] to induction chemotherapy undergo radiotherapy once daily (QD) 5 days a week for 6 weeks.  Patients with partial response, stable disease (SD), or progressive disease (PD) and normalization of tumor levels undergo second-look surgery.  Patients who achieve complete response or partial response after second-look surgery undergo radiotherapy. 

If your localized primary central nervous system tumor is a germinoma germ cell tumor, you will receive induction therapy comprising of carboplatin IV over 15-60 minutes on day 1 and etoposide IV over 1-2 hours on days 1-3.  You will receive up to 4 cycles (cycle equals 3 weeks or 21 days) of treatment, for a total of about 12 weeks of chemotherapy.  At the end of the 4 treatment cycles, there will be an evaluation (imaging studies of  your brain and spinal cord to see how the tumor has changed), and you will have tests done on your blood and cerebrospinal fluid (CSF).  If the evaluations after cycle 4 show no signs of disease, you will not have second-look surgery and will immediately go on to have radiation therapy at a reduced dose.  If the evaluations after cycle 4 show the disease has gotten a little better, stayed the same, or is getting worse, you will go on to have second-look surgery.  The purpose of the second-look surgery is to remove as much of the remaining tumor as possible and/or determine if what is left is not cancerous.  If the evaluations after cycle 4 show the disease has gotten a little better and you do not have second-look surgery, you will receive radiation at the standard dose.  It is possible that you will have no remaining disease after the second-look surgery.  If the remaining mass is found to be non-cancerous, you will go on to receive radiation therapy at a reduced dose.  Radiation therapy will be given to the ventricles once a day, 5 days a week, for a total fo about 4 or 5 weeks, depending on the radiation dose you receive. 

Eligibility

Inclusion Criteria

Must be 3-21 years of age

Must be newly diagnosed with localized primary central nervous system non germinomatous germ cell tumor (NGGCT) or localized primary central nervous system germinoma

Must have negative lumbar cerebrospinal fluid (CSF) cytology (lumbar CSF must be obtained unless medically contraindicated)

Must be enrolled on ALTE07C1 prior to enrollment on this study

Must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids