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Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma
This study is currently recruiting participants.
Study NCT00031590   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2002   Last Updated: July 21, 2009   History of Changes

March 8, 2002
July 21, 2009
April 2001
December 2011   (final data collection date for primary outcome measure)
  • Relapse-free survival [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Exoprimary-site relapse rate [ Designated as safety issue: No ]
  • Time to first recurrence [ Designated as safety issue: No ]
  • Degree of neurocognitive post-treatment decline or dysfunction as measured by an IQ test at baseline and after 1, 2, and 3 years [ Designated as safety issue: No ]
  • Degree of hearing loss [ Designated as safety issue: No ]
  • Decline in growth, sexual maturation, or need for hormone replacement [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Relapse-free survival
  • Survival
  • Exoprimary-site relapse rate
  • Time to first recurrence
  • Degree of neurocognitive post-treatment decline or dysfunction as measured by an IQ test at baseline and after 1, 2, and 3 years
  • Degree of hearing loss
  • Decline in growth, sexual maturation, or need for hormone replacement
  • Adverse events
Complete list of historical versions of study NCT00031590 on ClinicalTrials.gov Archive Site
 
 
 
Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma
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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: lomustine
  • Drug: vincristine sulfate
  • Experimental: Patients receive oral lomustine and cisplatin IV over 8 hours on day 0 and vincristine IV on days 0, 7, and 14.
  • Experimental: Patients receive cyclophosphamide IV on days 0 and 1 and etoposide IV on days 0 and 1 and then orally on days 14-34.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
 
December 2011   (final data collection date for primary outcome measure)

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
Both
3 Years to 30 Years
No
 
United States
 
NCT00031590
Peter C. Phillips, Children's Hospital of Philadelphia
CDR0000069075, CHP-693, CHP-IRB-2001-12-2301, NCI-V01-1680
Children's Hospital of Philadelphia
 
Study Chair: Peter C. Phillips, MD Children's Hospital of Philadelphia
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP