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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|ClinicalTrials.gov Identifier: NCT00653068|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2008
Results First Posted : February 13, 2017
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Childhood Atypical Teratoid/Rhabdoid Tumor||Procedure: autologous hematopoietic stem cell transplantation Radiation: 3-dimensional conformal radiation therapy Drug: methotrexate Drug: leucovorin calcium Drug: etoposide Drug: cyclophosphamide Drug: cisplatin Biological: filgrastim Drug: carboplatin Drug: thiotepa Drug: vincristine sulfate Other: laboratory biomarker analysis||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2015|
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.
Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity.
Procedure: autologous hematopoietic stem cell transplantation
Undergo autologous PBSC rescueRadiation: 3-dimensional conformal radiation therapy
Other Names:Drug: methotrexate
Other Names:Drug: leucovorin calcium
Given IV or orally
Other Names:Drug: etoposide
Other Names:Drug: cyclophosphamide
Other Names:Drug: cisplatin
Other Names:Biological: filgrastim
Given IV or SC
Other Names:Drug: carboplatin
Other Names:Drug: thiotepa
Other Names:Drug: vincristine sulfate
Other Names:Other: laboratory biomarker analysis
- Event-free Survival [ Time Frame: Up to 4 years after study enrollment ]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.
- Overall Survival (OS) [ Time Frame: Up to 4 years after study enrollment ]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.
- Toxic Death [ Time Frame: During and after completion of study treatment up to 1 year after enrollment. ]The number of patients who experience death that is considered to be primarily attributable to complications of treatment.
- Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy [ Time Frame: During protocol therapy up to 1 year after enrollment. ]Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653068
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|Principal Investigator:||Alyssa Reddy, MD||Children's Oncology Group|