A Study Using Chemotherapy Followed by Radiation Therapy in Treating Younger Patients with Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Newly diagnosed with localized primary CNS non germinomatous germ cell tumor (NGGCT) (Stratum 1). Stratum 1( NGGCT) patients must have one of the following criteria
    • Serum and/or CSF hCGβ > 100 mIU/mL
    • Any elevation of serum and CSF alpha-fetoprotein (AFP) > 10 ng/mL 
    • Greater than the institutional normal , irrespective of biopsy results
    • Any of the following elements on biopsy/resection, irrespective of serum and/or CSF hCGβ and AFP levels:
      • endodermal sinus tumor (yolk sac)
      • embryonal carcinoma
      • choriocarcinoma
      • malignant/immature teratoma, 
      • mixed GCT with malignant GCT elements
  • Or localized primary CNS germinoma (Stratum 2). Stratum 2 (Germinoma) must have one of the following criteria
    • Institutional normal AFP AND hCGβ 5 to ≤ 50 mIU/mL in serum and/or CSF, no histologic confirmation required
    • Bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF, no histologic confirmation required
    • Histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF
  • germ cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal +suprasellar), and ventricles
  • tumors present in the above mentioned locations and with unifocal parenchymal extension
  • Must have negative lumbar CSF cytology
    • lumbar CSF must be obtained unless medically contraindicated
  • Must be enrolled on ALTE07C1 prior to enrollment on ACNS1123
  • 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 if well controlled
  • Patients who had more than 1 prior surgery/biopsy are eligible

 

Exclusion Criteria

  • Patients with mature teratoma with normal tumor markers
  • Patients with tumors located outside the ventricles (basal ganglia, thalamus)
  • Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology
  • Must not be in status, coma, or assisted ventilation prior to study enrollment
  • Female patients who are pregnant
  • Lactating females unless they have agreed not to breastfeed their infants
  • Female patients of childbearing potential unless a negative pregnancy test result has been obtained
  • Sexually active patients of reproductive potential unless they have agreed to use an effective contraceptive method for the duration of their study participation
  • Must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola A Arndt, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20152249

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