Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	3 to 30 at initial diagnosis	Other	CHP-693 CHP-IRB-2001-12-2301, NCI-V01-1680, NCT00031590

Objectives

1. 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.
2. Evaluate the acute and subacute toxicity of this regimen in these patients.
3. Evaluate the late neurotoxic effects of low-dose craniospinal radiotherapy, in terms of cognitive, endocrinologic, and auditory function, in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed posterior fossa primitive neuroectodermal tumor or medulloblastoma



• Standard-risk disease
  • No residual tumor greater than 1.5 cm² 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

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

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

Expected Enrollment

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

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Children's Hospital of Philadelphia

Peter Phillips, MD, Protocol chair		Ph: 215-590-2107

U.S.A.
California
	Palo Alto
	Lucile Packard Children's Hospital at Stanford University Medical Center
		Paul Fisher, MD, MHS	Ph:  650-497-8953
			Email: pfisher@stanford.edu
Georgia
	Egleston
	Winship Cancer Institute of Emory University
		Anna Janss, MD, PhD	Ph:  404-257-3480 888-946-7447
Pennsylvania
	Philadelphia
	Children's Hospital of Philadelphia
		Peter Phillips, MD	Ph:  215-590-3129

Registry Information
Official Title		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)
Trial Start Date		2001-04-10
Trial Completion Date		2011-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00031590 1
Date Submitted to PDQ		2001-10-10
Information Last Verified		2009-06-28

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00031590