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

Contact Information

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Min Wang (650) 736-4281
To view all clinical trials at Stanford, please see the Clinical Trials Directory.

Brief

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.

Recruiting Status:

Recruiting

Stanford Recruiting Status:

Recruiting

Condition(s):

Intervention(s):

  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: lomustine
  • Drug: vincristine
  • Procedure: adjuvant therapy
  • Procedure: chemotherapy
  • Procedure: radiation therapy

Phase:

Phase 2

Eligibility

Ages Eligible for Study:

3 years to 30 years

Genders Eligible for Study:

Male and Female

Health of Volunteers:

People with the conditions listed in this trial can participate as controls.

Key Inclusion Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed posterior fossa primitive neuroectodermal tumor or medulloblastoma

- Standard-risk disease
o No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI
o No tumor in the spinal or cerebral subarachnoid space by MRI
o No tumor in the subarachnoid space by CSF cytology
o 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:
o 3 to 30 at initial diagnosis

Performance status:
o Not specified

Life expectancy:
o Not specified

Hematopoietic:
o Not specified

Hepatic:
o Not specified

Renal:
o 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

Key Exclusion Criteria:

Additional Study Details

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)

Anticipated start date:

9/25/2001

Lead Sponsor:

CHP - Children

Investigator(s):

Study Type:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized

Masking:

Open

Control:

none

Assignment:

Single Group

Endpoints:

Safety/Efficacy

Primary Outcomes:

  • 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
  • Survival
  • Exoprimary-site relapse rate
  • Relapse-free survival
  • Time to first recurrence

Total Number to be Enrolled:

50

Total Number to be Enrolled at Stanford:

10

More Information

Related Links:

Trial Unique Id: SU-07232007-310

Secondary ID(s):

  • 77591
  • CHP-693
  • CHP-IRB-2001-12-2301
  • NCI-V01-1680
  • NCT00031590
  • PEDSCHP693

Locations & Contacts

Stanford Locations & Contacts:

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

Primary Contact:

Min Wang (650) 736-4281

Non-Stanford Locations:

The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.

This listing was last updated:

8/24/2009

PLEASE NOTE:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.

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