Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma



Status:Terminated
Conditions:Brain Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:3 - 30
Updated:4/21/2016
Start Date:April 2001
End Date:May 2011

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Study Of Reduced Dose Craniospinal Radiotherapy (1800 cGy) And Chemotherapy In Children With Newly-Diagnosed Standard-Risk Posterior Fossa Primitive Neuro-ectodermal Tumor (PNET/Medulloblastoma)

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy work in different ways to stop tumor cells from dividing so they stop growing
or die. Combining low-dose radiation therapy with combination chemotherapy may be effective
in treating primitive neuroectodermal tumor and medulloblastoma.

PURPOSE: This phase II trial is studying giving low-dose radiation therapy together with
combination chemotherapy after surgery to see how well it works in treating children with
newly diagnosed primitive neuroectodermal tumor or medulloblastoma.

OBJECTIVES:

- Reduce the late cognitive, auditory, and endocrinologic effects in children with newly
diagnosed standard-risk posterior fossa primitive neuroectodermal tumor or
medulloblastoma by reducing the adjuvant craniospinal radiotherapy dose by 25%, but
maintaining a therapeutic efficacy (86% 3-year relapse-free survival) of current
standard therapy by using maintenance chemotherapy comprising lomustine, cisplatin, and
vincristine alternated with cyclophosphamide and etoposide.

- Evaluate the acute and subacute toxicity of this regimen in these patients.

- Evaluate the late neurotoxic effects of low-dose craniospinal radiotherapy, in terms of
cognitive, endocrinologic, and auditory function, in these patients.

OUTLINE: This is a multicenter study.

- Adjuvant induction chemoradiotherapy: Beginning within 28 days after prior resection,
patients undergo radiotherapy to the craniospinal axis 5 days a week for 2 weeks and
then conformal radiotherapy to the tumor bed 5 days a week for 4 weeks. Beginning 1
week after the initiation of radiotherapy, patients receive vincristine IV weekly for 6
weeks.

- Maintenance chemotherapy: Beginning 4 weeks after the completion of induction
chemoradiotherapy, patients receive two 6-week courses of regimen A as outlined below
alternated with one 6-week course of regimen B as outlined below for a total of 9
courses (6 courses of regimen A and 3 courses of regimen B).

- Regimen A: Patients receive oral lomustine and cisplatin IV over 8 hours on day 0
and vincristine IV on days 0, 7, and 14.

- Regimen B: Patients receive cyclophosphamide IV on days 0 and 1 and etoposide IV
on days 0 and 1 and then orally on days 14-34.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 3 years.

Inclusion Criteria:

1. Histologically confirmed posterior fossa primitive neuroectodermal tumor or
medulloblastoma

2. Standard-risk disease

3. No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI

- No tumor in the spinal or cerebral subarachnoid space by MRI

- No tumor in the subarachnoid space by Cerebrospinal fluid (CSF)

- No failure to perform staging studies (spine MRI and CSF cytology)
preoperatively or postoperatively

4. Must begin radiotherapy on study within 28 days after surgery

Exclusion Criteria:

1. Prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not
allowed.

2. Pregnant females will not be eligible

3. Patients must begin radiotherapy on protocol within 28 days of completion of surgery.
Exceptions need to be approved by the Principal Investigator.

4. Patients with the following will not be eligible:

- > 1.5cm3 residual tumor following resection as indicated by post-operative MRI.

- tumor in spinal or cerebral subarachnoid space either by MRI of brain and spine

- tumor in subarachnoid space by CSF cytology

- failure to perform staging studies (spine MRI, CSF cytology) either pre- or
post- operatively
We found this trial at
3
sites
1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Palo Alto, CA
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