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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00653068
  Purpose

RATIONALE: Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.

PURPOSE: This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: etoposide phosphate
Drug: filgrastim
Drug: methotrexate
Drug: thiotepa
Drug: vincristine sulfate
Procedure: 3-dimensional conformal radiation therapy
Procedure: autologous hematopoietic stem cell transplantation
Procedure: immunohistochemistry staining method
Procedure: mutation analysis
Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Cyclophosphamide Carboplatin Filgrastim Etoposide Methotrexate Vincristine sulfate Vincristine Cisplatin Thiotepa Etoposide phosphate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation

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

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Toxic death, defined as death primarily attributable to complications of treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity and safety [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2008
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of CNS atypical teratoid/rhabdoid tumor (AT/RT) or tumors that have a mutation of the INI1 gene (even if the tumor does not have the usual histologic characteristics of AT/RT)

    • Patients with extraneural metastasis (M4) or renal rhabdoid tumors are not eligible
    • Patients with MRI evidence of spinal disease are eligible
  • Must have undergone definitive surgery in the past 31 days
  • Cranial MRI (with and without gadolinium) must be done pre-operatively

    • Post-operatively, cranial MRI (with and without gadolinium) must be done, preferably within 48 hours of surgery or 10-28 days after surgery
  • Entire spinal MRI must be obtained either pre-operatively (with gadolinium) or post-operatively (10- 28 days after surgery), prior to study enrollment (with and without gadolinium)

PATIENT CHARACTERISTICS:

  • Life expectancy > 8 weeks
  • ANC > 1,000/μL
  • Platelet count > 100,000/μL (transfusion independent)
  • Hemoglobin > 8 g/dL (RBC transfusions allowed)
  • Creatinine clearance (minimum of 12-24 hour urine collection) or radioisotope GFR ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST and ALT < 2 times ULN for age
  • Shortening fraction of ≥ 27% by echocardiogram OR ejection fraction of ≥ 47% by radionuclide angiogram
  • No evidence of dyspnea at rest
  • Pulse oximetry > 94% on room air
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy or chemotherapy except for the following:

    • Patients enrolled on protocol ACNS0334 whose tumors demonstrate the INI1 gene mutation are eligible to transfer to this study even if they have received one course of induction therapy (these patients must be re-consented to treatment and restaged)
    • Prior corticosteroids allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653068

Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer     205-934-0309        
United States, California
Children's Hospital Central California Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse     559-353-5480        
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Alyssa T. Reddy, MD Children's Hospital of Alabama at University of Alabama at Birmingham
  More Information

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

Study ID Numbers: CDR0000592812, COG-ACNS0333
Study First Received: April 3, 2008
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00653068  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood atypical teratoid/rhabdoid tumor

Study placed in the following topic categories:
Rhabdoid Tumor
Vincristine
Central Nervous System Neoplasms
Cyclophosphamide
Carboplatin
Etoposide phosphate
Rhabdoid tumor
Thiotepa
Folic Acid
Cisplatin
Methotrexate
Etoposide
Nervous System Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Mitosis Modulators
Nervous System Diseases
Enzyme Inhibitors
Antimitotic Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on January 16, 2009