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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)


Phase 2
3 Years
30 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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)


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


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival

Safety Issue:

No

Principal Investigator

Peter C. Phillips, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Philadelphia

Authority:

Unspecified

Study ID:

CDR0000069075

NCT ID:

NCT00031590

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798