Clinical Trial: Intrathecal and Systemic Chemotherapy Combined With Radiation Therapy in Treating Young Patients With Newly Diagnosed Central Nervous System Atypical Teratoid/Rhabdoid Tumors

This study is currently recruiting patients.

Sponsors and Collaborators: Dana-Farber/Harvard Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.

Condition Treatment or Intervention Phase
childhood rhabdoid tumor of the central nervous system
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: dactinomycin
 Drug: dexrazoxane
 Drug: doxorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: hydrocortisone
 Drug: leucovorin calcium
 Drug: methotrexate
 Drug: temozolomide
 Drug: vincristine
 Procedure: biological response modifier therapy
 Procedure: chemoprotection
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: radiation therapy
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Multi-Agent Intrathecal and Systemic Chemotherapy With Radiotherapy in Children With Newly Diagnosed Central Nervous System Atypical Teratoid/Rhabdoid Tumors

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine the toxicity profile and tolerability of this regimen in these patients.
  • Determine the chemosensitivity of these patients' tumors by MRI after an attempt at maximum surgical resection after 2 courses of this regimen.
  • Determine the predictive value of the INI 1 gene mutation in determining prognosis by comparing tumor samples from patients with vs without this mutation treated with this regimen.

OUTLINE: This is a multicenter study.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1.5 years.

Eligibility

Ages Eligible for Study:  up to  18 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and under

Performance status

  • Karnofsky 50-100% OR
  • Lansky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin > 10 g/dL
  • Absolute neutrophil count > 1,000/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • SGPT < 10 times normal

Renal

  • Creatinine ≤ 1.5 times normal

Other

  • Willing to have placement of central venous access line

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior steroids allowed

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other


Location and Contact Information


California
      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305-5826,  United States; Recruiting
Paul Graham Fisher, MD, MHS  650-723-6841    pfisher@stanford.edu 

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8064,  United States; Recruiting
Jack van Hoff, MD  203-785-4640    jack.vanhoff@yale.edu 

Georgia
      AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta,  Georgia,  30342,  United States; Recruiting
Claire Mazewski, MD  404-257-3240 

Illinois
      Children's Memorial Hospital - Chicago, Chicago,  Illinois,  60614,  United States; Recruiting
Stewart Goldman, MD  773-880-4585 

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21287-5001,  United States; Recruiting
Kenneth J. Cohen, MD  410-614-5055    kcohen@jhmi.edu 

Massachusetts
      Children's Hospital Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
Karen Chayt Marcus, MD  617-355-8399    kmarcus@lroc.harvard.edu 

      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
Mark William Kieran, MD  617-632-4907 

Minnesota
      Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis,  Minnesota,  55118,  United States; Recruiting
Anne Elizabeth Bendel, MD  612-813-5940    anne.bendel@childrenshc.org 

Nevada
      Sunrise Hospital and Medical Center, Las Vegas,  Nevada,  89109,  United States; Recruiting
Jonathan Bernstein, MD  702-732-0971    jonbern1@aol.com 

Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Joanne M. Hilden, MD  216-444-8407    hildenj@ccf.org 

Texas
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9063,  United States; Recruiting
Daniel C. Bowers, MD  214-648-3896 

Study chairs or principal investigators

Mark William Kieran, MD,  Principal Investigator,  Dana-Farber/Harvard Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000365641; DFCI-02294; UTSMC-0403210; JHOC-JHM-IRB5; SUMC-78899; CHP-2003-2-3169; CCF-IRB-6140; CHCM-0302-004; NCT00084838
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00084838
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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