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Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on March 8, 2002.   Last Updated on November 10, 2011   History of Changes
Sponsor: Children's Hospital of Philadelphia
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031590
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
 Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: lomustine
Drug: vincristine sulfate
 Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cyclophosphamide Vincristine Lomustine Cisplatin Etoposide Etoposide phosphate Vincristine sulfate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: April 2001
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A
Patients receive oral lomustine and cisplatin IV over 8 hours on day 0 and vincristine IV on days 0, 7, and 14.
 Drug: cisplatin
Given orally and IV
Drug: lomustine
Given orally and IV
Drug: vincristine sulfate
Given orally and IV
Experimental: 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.
 Drug: cyclophosphamide
Given orally and IV
Drug: etoposide
Given orally and IV

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031590

Locations
United States, California
Lucile Packard Children's Hospital at Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Paul G. Fisher, MD, MHS     650-497-8953     pfisher@stanford.edu    
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute     404-778-1900        
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104-4318
Contact: Peter C. Phillips, MD     215-590-3129        
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Study Chair: Peter C. Phillips, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Phillips, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00031590     History of Changes
Other Study ID Numbers: CDR0000069075, CHP-693, CHP-IRB-2001-12-2301, NCI-V01-1680
Study First Received: March 8, 2002
Last Updated: November 10, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated childhood medulloblastoma

Additional relevant MeSH terms:
Medulloblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
 Cisplatin
Cyclophosphamide
Etoposide
Lomustine
Vincristine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 12, 2012



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