Overview

Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. PURPOSE: This phase III trial is studying how well giving combination chemotherapy with or without etoposide followed by an autologous stem cell transplant works in treating young patients with previously untreated malignant brain tumors.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital Los Angeles
Treatments:
Carboplatin
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Methotrexate
Temozolomide
Thiotepa
Vincristine
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed malignant brain tumor, including any of the following:

- Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET)*

- All stages allowed

- Must be < 4 years of age at diagnosis unless there is evidence of
postoperative residual tumor (> 1.5 cm² tumor area) or evidence of neuraxis
or extraneural dissemination (high-stage)

- Medulloblastoma, cerebral neuroblastoma, and ependymoblastoma allowed

- Low-stage (standard-risk) medulloblastoma not allowed in patients > 4
years of age

- Ependymoma*

- All stages and locations allowed

- Cellular and anaplastic subtypes allowed (no myxopapillary ependymomas of
the spinal cord)

- Must be < 36 months of age at diagnosis for posterior fossa tumor OR < 72
months of age for supratentorial tumor

- Evidence of neuraxis dissemination irrespective of primary site

- No cellular (low-grade) supratentorial ependymomas at any age with complete
resection of parenchymally based (i.e., not periventricular) supratentorial
tumors

- Brain stem tumor*

- All stages allowed irrespective of extent of resection

- No unbiopsied diffuse intrinsic pontine tumor

- Tumor pathologically confirmed to be either malignant glioma or PNET allowed

- High-grade glioma**

- Primary atypical teratoid/rhabdoid tumor of the CNS*

- Choroid plexus carcinoma or atypical choroid plexus papilloma*

- All stages and locations allowed

- Anaplastic astrocytoma**

- Glioblastoma multiforme**

- Anaplastic oligodendroglioma**

- Anaplastic ganglioglioma**

- Other anaplastic mixed gliomas**

- Small-cell glioblastoma**

- Giant-cell glioblastoma**

- Gliosarcoma**

- The following diagnoses or subtypes are not allowed:

- Choroid plexus papilloma

- Pineocytoma

- Low-grade mixed glioma

- Primary CNS germ cell tumor

- Primary CNS lymphoma

- Solid leukemic lesions (i.e., chloromas, granulocytic sarcomas)

- Pleomorphic xanthoastrocytoma, low grade

- Desmoplastic ganglioglioma

- Low-grade astrocytoma

- Previously untreated disease

- Has undergone definitive surgery within the past 42 days NOTE: *Patients receive
treatment according to regimen D2

NOTE: **Patients receive treatment according to regimen C

PATIENT CHARACTERISTICS:

- Bilirubin < 1.5 mg/dL

- ALT and AST < 2.5 times upper limit of normal

- Creatinine clearance and/or glomerular filtration rate ≥ 60 mL/min

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radiotherapy or chemotherapy

- Prior corticosteroids allowed

- No concurrent corticosteroids for antiemesis only

- No concurrent brachytherapy or electron radiotherapy

- No concurrent dairy products or grapefruit juice with temozolomide administration