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
|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|
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|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 rescue
Radiation: 3-dimensional conformal radiation therapy
Drug: leucovorin calcium
Given IV or orally
Given IV or SC
Drug: vincristine sulfate
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.
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|