Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors
Condition: Brain Tumor; Central Nervous System Tumors; Childhood Germ Cell Tumor
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: carboplatin; etoposide; ifosfamide; thiotepa; adjuvant therapy; conventional surgery; neoadjuvant therapy; peripheral blood stem cell transplantation; radiation therapy
Intervention description: Given IV; Given IV; Given IV; Given IV; craniospinal irradiation
Intervention MeSH terms: Carboplatin; Etoposide; Ifosfamide; Isophosphamide mustard; Thiotepa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 3 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: childhood central nervous system germ cell tumor; childhood teratoma; recurrent childhood malignant germ cell tumor; childhood central nervous system choriocarcinoma; childhood central nervous system embryonal tumor; childhood central nervous system germinoma; childhood central nervous system mixed germ cell tumor; childhood central nervous system teratoma; childhood central nervous system yolk sac tumor; recurrent childhood central nervous system embryonal tumor

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
      the tumor so that it is no longer present by conventional imaging and tumor markers from
      serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor
      cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of
      chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill
      more tumor cells.

      PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without
      surgery and with or without high dose chemotherapy and peripheral stem cell transplantation,
      can increase response rates prior to radiation therapy and increase progression free and
      overall surviving patients with newly diagnosed intracranial germ cell tumors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  One of the following diagnoses:

               -  Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT)
                  of 1 of the following types:

                    -  Endodermal sinus tumor (yolk sac tumor)

                    -  Embryonal carcinoma

                    -  Choriocarcinoma

                    -  Immature teratoma and teratoma with malignant transformation

                    -  Mixed germ cell tumor

               -  Histologically confirmed germinoma with elevation of serum/CSF beta human
                  chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF
                  alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm

               -  Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta
                  HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above
                  institutional norm

          -  Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a
             NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible

          -  Initial diagnosis within the past 31 days

        PATIENT CHARACTERISTICS:

        Age

          -  3 to 24 at diagnosis

        Performance status

          -  No minimum performance level

        Life expectancy

          -  At least 8 weeks

        Hematopoietic

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 100,000/mm^3 (transfusion independent)

          -  Hemoglobin at least 10.0 g/dL (transfusion allowed)

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  ALT no greater than 2.5 times ULN

        Renal

          -  Creatinine no greater than 1.5 times ULN OR

          -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

        Pulmonary

          -  No assisted ventilation

        Other

          -  Seizure disorders allowed

          -  No patients in status or coma

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patient must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Prior corticosteroids allowed

          -  Concurrent corticosteroids allowed

          -  Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone,
             estrogen, desmopressin acetate)

          -  No concurrent growth hormone therapy

        Radiotherapy

          -  Not specified

        Surgery

          -  More than 1 prior surgery allowed

        Other

          -  No other prior therapy for malignancy