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Brain and Central Nervous System Tumors

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

Sponsored by St. Jude Children's Research Hospital

About this trial

Last updated 2 years ago

Study ID

SJMB03

Status

Active, not recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
3 to 21 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

Drugs used in chemotherapy, such as vincristine, cisplatin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. It is not yet known which radiation therapy regimen combined with chemotherapy and donor stem cell transplant is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. This phase III trial is studying two different regimens of radiation therapy when given together with chemotherapy and autologous stem cell transplant to see how well they work in treating patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor. PRIMARY OBJECTIVE: - To assess the relationship between ERBB2 protein expression in tumors and progression-free survival probability for patients with medulloblastoma. - To estimate the frequency of mutations associated with SHH and WNT tumors (as defined by gene expression profiling) via targeted sequencing performed in an independent cohort of WNT and SHH tumors (also defined by gene expression profiling).

What are the Participation Requirements?

DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of 1 of the following:

- Medulloblastoma

- Supratentorial primitive neuroectodermal tumor (PNET)

- PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma)

- Atypical teratoid rhabdoid tumor (ATRT)

- Definitive surgery for CNS tumor within the past 31 days

- Meets one of the following risk criteria:

- Average-risk disease

- Localized disease with no overt evidence of invasion beyond the posterior
fossa (or supratentorial compartment for PNET or ATRT) by intraoperative
observations of the neurosurgeon AND postoperative CT scan or MRI

- T4 disease eligible if all of the following are true:

- Gross total resection determined by intraoperative observations of the
neurosurgeon AND postoperative CT scan or MRI

- Residual tumor or imaging abnormality whose size is < 1.5 cm^2

- No evidence of CNS or extraneural metastasis by MRI of the spine (with
and without contrast agent) or CT-based myelogram AND by cytologic
examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after
surgery

- Brain stem invasion allowed in the absence of residual tumor (tumor < 1.5
cm^2 by imaging)

- High-risk disease meeting one of the following criteria:

- Metastatic disease within the neuraxis (i.e., evidence of subarachnoid
dissemination by imaging and/or cytologic examination of CSF)

- Presence of residual disease > 1.5 cm^2 at the primary site after surgery

PATIENT CHARACTERISTICS:

Age

- 3 to 21 at diagnosis

Performance status

- Lansky 30-100% (< 10 years old)

- Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome)

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin > 8 g/dL

- WBC > 2,000/mm^3

- Absolute neutrophil count > 500/mm^3

- Platelet count > 50,000/mm^3

Hepatic

- ALT < 5 times normal

- Bilirubin < 3.0 mg/dL

Renal

- Creatinine < 2.0 mg/dL OR

- Creatinine clearance > 70 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroid therapy allowed

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

Locations

Location

Status