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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00653068
Registration number
NCT00653068
Ethics application status
Date submitted
3/04/2008
Date registered
4/04/2008
Date last updated
23/04/2024
Titles & IDs
Public title
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
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Scientific title
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation
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Secondary ID [1]
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NCI-2009-00337
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Secondary ID [2]
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ACNS0333
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Atypical Teratoid/Rhabdoid Tumor
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Condition category
Condition code
Cancer
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Kidney
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - 3-Dimensional Conformal Radiation Therapy
Treatment: Surgery - Autologous Hematopoietic Stem Cell Transplantation
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Etoposide
Other interventions - Filgrastim
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Methotrexate
Treatment: Drugs - Thiotepa
Treatment: Drugs - Vincristine Sulfate
Experimental: Arm I (chemotherapy, autologous PBSC, 3D-CRT) - Patients receive vincristine IV on days 1, 8, and 15; high-dose methotrexate IV on day 1; leucovorin calcium orally or IV; etoposide IV on days 4, 5, and 6; cyclophosphamide IV on days 4 and 5; cisplatin IV on day 6, and G-CSF IV or SC on day 7 until ANC recovers.
Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers. Treatment with consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After consolidation therapy, patients undergo 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks.
Experimental: Arm II (chemotherapy, 3D-CRT, autologous PBSC) - Patients receive vincristine IV on days 1, 8, and 15; high-dose methotrexate IV on day 1; leucovorin calcium orally or IV; etoposide IV on days 4, 5, and 6; cyclophosphamide IV on days 4 and 5; cisplatin IV on day 6, and G-CSF IV or SC on day 7 until ANC recovers.
Patients undergo 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks. Within 2-6 weeks after completion of radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Treatment: Other: 3-Dimensional Conformal Radiation Therapy
Undergo 3D-CRT
Treatment: Surgery: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous PBSC rescue
Treatment: Drugs: Carboplatin
Given IV
Treatment: Drugs: Cisplatin
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Etoposide
Given IV
Other interventions: Filgrastim
Given IV or SC
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Leucovorin Calcium
Given IV or PO
Treatment: Drugs: Methotrexate
Given IV
Treatment: Drugs: Thiotepa
Given IV
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Surgery
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Intervention code [3]
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Treatment: Drugs
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Intervention code [4]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival
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Assessment method [1]
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Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact.
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Timepoint [1]
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Up to 4 years after study enrollment
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored.
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Timepoint [2]
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Up to 4 years after study enrollment
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Primary outcome [3]
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Toxic Death
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Assessment method [3]
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The number of patients who experience death that is considered to be primarily attributable to complications of treatment.
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Timepoint [3]
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During and after completion of study treatment up to 1 year after enrollment.
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Secondary outcome [1]
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Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
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Assessment method [1]
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Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.
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Timepoint [1]
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During protocol therapy up to 1 year after enrollment.
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Eligibility
Key inclusion criteria
- 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 extra neural 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)
- Life expectancy > 8 weeks
- ANC > 1,000/uL
- Platelet count > 100,000/uL (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
- 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
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2024
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Sample size
Target
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Accrual to date
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Final
70
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Royal Children's Hospital - Parkville
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Recruitment hospital [2]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment postcode(s) [2]
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6008 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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California
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Connecticut
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Delaware
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District of Columbia
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase III trial studies the side effects of combination chemotherapy, 3-dimensional
conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to
see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of
the central nervous system. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00653068
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alyssa T Reddy
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Address
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Children's Oncology Group
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00653068
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