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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)
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed posterior fossa primitive neuroectodermal tumor or
medulloblastoma
- Standard-risk disease
- 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 CSF cytology
- No failure to perform staging studies (spine MRI and CSF cytology)
preoperatively or postoperatively
- Must begin radiotherapy on study within 28 days after surgery
PATIENT CHARACTERISTICS:
Age:
- 3 to 30 at initial diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior antitumor chemotherapy
Endocrine therapy:
- Prior corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy
Surgery:
- See Disease Characteristics
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| NCT ID: |
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NCT00031590 |
| Primary Contact: |
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Study Chair
Peter C. Phillips, MD
Children's Hospital of Philadelphia
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Peter C. Phillips, MD
Phone: 215-590-3129
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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