Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

Not Recruiting

Trial ID: NCT01602666


This phase II trial studies how well chemotherapy followed by radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors that have not spread to other parts of the brain, spinal canal, or body (localized). Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may kill more tumor cells.

Official Title

Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)

Stanford Investigator(s)

Paul Graham Fisher, MD
Paul Graham Fisher, MD

Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health


Inclusion Criteria:

   - Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or
   localized primary CNS germinoma (Stratum 2); germ cell tumors located in the
   suprasellar, pineal, bifocal (pineal + suprasellar) and ventricles are eligible;
   tumors present in the above mentioned locations and with unifocal parenchymal
   extension are eligible

      - Stratum 1(NGGCT): Patients must have one of the following criteria:

         - Patients with serum and/or CSF hCGbeta > 100 mIU/mL or any elevation of
         serum and/or CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the
         institutional normal are eligible, irrespective of biopsy results

         - Patients with any of the following elements on biopsy/resection are
         eligible, irrespective of serum and/or CSF hCGbeta and AFP levels:
         endodermal sinus tumor (yolk sac), embryonal carcinoma, choriocarcinoma,
         malignant/immature teratoma, and mixed GCT with malignant GCT elements

      - Stratum 2 (Germinoma): Patients must have both serum and CSF markers obtained
      (unless obtaining CSF is medically contraindicated) and must have one of the
      following criteria to be eligible:

         - Patients with institutional normal AFP (or =< 10 ng/mL if no institutional
         normal exists) in both serum and CSF (unless medically contraindicated) AND
         hCGbeta 5 to =< 50 mIU/mL in serum and/or CSF (unless medically
         contraindicated) (only 1 is required to be elevated) are eligible; no
         histologic confirmation required

         - Patients with bifocal (pineal + suprasellar) involvement or pineal lesion
         with diabetes insipidus (D1) AND hCGbeta =< 100 mIU/mL in serum and/or CSF
         AND institutional normal AFP (or =< 10 ng/mL if no institutional normal
         exists) in both serum and CSF (unless medically contraindicated) are
         eligible; no histologic confirmation required

         - Patients with histologically confirmed germinoma or germinoma mixed with
         mature teratoma and hCGbeta =< 100 mIU/mL in serum and/or CSF and
         institutional normal AFP (or =< 10 ng/mL if no institutional normal exists)
         in both serum and CSF (unless medically contraindicated) are eligible

   - All patients must have a cranial MRI with and without gadolinium at diagnosis/prior to
   enrollment; if surgical resection is performed, patients must have pre-operative and
   post-operative cranial MRI with and without gadolinium; the post-operative brain MRI
   should be obtained within 72 hours of surgery; if patient has a biopsy only,
   post-operative cranial MRI is recommended but not required; all patients must have a
   spine MRI with gadolinium obtained at diagnosis/prior to enrollment; Note: if the
   spine study is performed for the first time after surgical resection or biopsy, it is
   recommended to be obtained with and without gadolinium

   - Lumbar CSF must be obtained prior to study enrollment unless medically
   contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at
   this time, then it should be performed at least 10 days following surgery before study
   enrollment; false positive cytology can occur within 10 days of surgery; Note:
   patients with positive CSF cytology obtained prior to 10 days after surgery may have
   cytology repeated to determine eligibility

   - Patients must have CSF tumor markers obtained prior to enrollment unless medically
   contraindicated; ventricular CSF obtained at the time of CSF diversion procedure (if
   performed) is acceptable for tumor markers but lumbar CSF is preferred; in case CSF
   diversion and biopsy/surgery are combined, CSF tumor markers should be collected first

   - Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must
   be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical

   - Peripheral absolute neutrophil count (ANC) >= 1,000/uL

   - Platelet count >= 100,000/uL (transfusion independent)

   - Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)

   - Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73
   m^2 OR serum creatinine based on age/gender as follows:

      - 0.8 mg/dL (2 to < 6 years of age)

      - 1.0 mg/dL (6 to < 10 years of age)

      - 1.2 mg/dL (10 to < 13 years of age)

      - 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)

      - 1.7 mg/dL (male) and 1.4 mg/dL (female) (>= 16 years of age)

   - Total bilirubin =< 1.5 times upper limit of normal (ULN) for age

   - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
   serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5
   times ULN

   - Patients with seizure disorder may be enrolled if well controlled

   - Patients must not be in status, coma, or assisted ventilation prior to study

Exclusion Criteria:

   - Patients with mature teratoma or completely resected immature teratoma with normal
   tumor markers are not eligible

   - Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not

   - Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology
   (unless medically contraindicated) are not eligible

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

   - Female patients who are pregnant are ineligible

   - Lactating females are not eligible unless they have agreed not to breastfeed their

   - Female patients of childbearing potential are not eligible unless a negative pregnancy
   test result has been obtained

   - Sexually active patients of reproductive potential are not eligible unless they have
   agreed to use an effective contraceptive method for the duration of their study

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met


drug: carboplatin

drug: etoposide

drug: ifosfamide

radiation: 3-dimensional conformal radiation therapy

radiation: intensity-modulated radiation therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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