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Trial record 1 of 1 for:    NCT00653068
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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 November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00653068
First received: April 3, 2008
Last updated: November 3, 2012
Last verified: November 2012
History of Changes
  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
 Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: etoposide phosphate
Drug: methotrexate
Drug: thiotepa
Drug: vincristine sulfate
Genetic: mutation analysis
Other: immunohistochemistry staining method
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: 3-dimensional conformal radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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: June 2017 (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

  Show 87 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Alyssa T. Reddy, MD Children's Hospital of Alabama at University of Alabama at Birmingham
  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: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT00653068     History of Changes
Other Study ID Numbers: CDR0000592812, COG-ACNS0333
Study First Received: April 3, 2008
Last Updated: November 3, 2012
Health Authority: Unspecified

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

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Rhabdoid Tumor
Neoplasms by Site
Neoplasms
Nervous System Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Etoposide phosphate
Cisplatin
Cyclophosphamide
Etoposide
Methotrexate
Thiotepa
Vincristine
 Carboplatin
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 19, 2013