Trial Search Results

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

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 or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Procedure: therapeutic conventional surgery
  • Radiation: 3-dimensional conformal radiation therapy
  • Radiation: intensity-modulated radiation therapy
  • Drug: carboplatin
  • Drug: etoposide
  • Drug: ifosfamide

Phase:

Phase 2

Eligibility


Inclusion and Exclusion Criteria:

   - Patients must be newly diagnosed with localized primary CNS non germinomatous germ
   cell tumor (NGGCT) (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ
   cell tumors (GCTs) 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 hCGβ > 100 mIU/mL or any elevation of serum
         and 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 hCGβ 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 one of the following criteria:

         - Patients with institutional normal AFP AND hCGβ 5 to ≤ 50 mIU/mL in serum
         and/or CSF are eligible; no histologic confirmation required

         - Patients with bifocal (pineal + suprasellar) involvement or pineal lesion
         with diabetes insipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP
         in serum and/or CSF are eligible; no histologic confirmation required

         - Patients with histologically confirmed germinoma or germinoma mixed with
         mature teratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum
         and/or CSF are eligible

   - Patients must have negative lumbar CSF cytology; lumbar CSF must be obtained unless
   medically contraindicated

   - Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123

   - Patients with mature teratoma with normal tumor markers are not eligible

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

   - Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are
   not eligible

   - Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL

   - Platelet count ≥ 100,000/μL (transfusion independent)

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

   - Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m² OR serum creatinine based
   on age/gender as follows:

      - 0.4 mg/dL ( 1 month to < 6 months of age)

      - 0.5 mg/dL (6 months to < 1 year of age)

      - 0.6 mg/dL (1 to < 2 years of age)

      - 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)

   - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
   serum glutamic 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
   enrollment

   - Female patients who are pregnant are ineligible

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

   - 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
   participation

   - Patients who had more than 1 prior surgery/biopsy are eligible

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

Ages Eligible for Study

3 Years - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting