NCT00653068|CompletedPhase 3Results

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

Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation

Children's Oncology Group ClinicalTrials.gov

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7 other identifiers

ACNS0333NCI-2009-00337CDR000059281209-0058COG-ACNS0333U10CA098543U10CA180886

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredApr 2008

StartedFeb 2009

CompletionMar 2024

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach

3 countries

94 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

15.1 years study duration

First Submitted

Initial submission to the registry

April 3, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed

10 months until next milestone

Study Start

First participant enrolled

February 10, 2009

Completed

7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2016

Completed

5 months until next milestone

Results Posted

Study results publicly available

February 13, 2017

Completed

7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed

Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

7.6 years

First QC Date

April 3, 2008

Results QC Date

December 20, 2016

Last Update Submit

April 3, 2024

Conditions

Childhood Atypical Teratoid/Rhabdoid Tumor

Outcome Measures

Primary Outcomes (3)

Event-free Survival
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.
Up to 4 years after study enrollment
Overall Survival (OS)
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.
Up to 4 years after study enrollment
Toxic Death
The number of patients who experience death that is considered to be primarily attributable to complications of treatment.
During and after completion of study treatment up to 1 year after enrollment.

Secondary Outcomes (1)

Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
During protocol therapy up to 1 year after enrollment.

Study Arms (2)

Arm I (chemotherapy, autologous PBSC, 3D-CRT)

EXPERIMENTAL

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.

Radiation: 3-Dimensional Conformal Radiation TherapyProcedure: Autologous Hematopoietic Stem Cell TransplantationDrug: CarboplatinDrug: CisplatinDrug: CyclophosphamideDrug: EtoposideBiological: FilgrastimOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MethotrexateDrug: ThiotepaDrug: Vincristine Sulfate

Arm II (chemotherapy, 3D-CRT, autologous PBSC)

EXPERIMENTAL

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.

Interventions

3-Dimensional Conformal Radiation TherapyRADIATION

Undergo 3D-CRT

Also known as: 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D radiotherapy, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy, Radiation, 3D Conformal, Three dimensional external beam radiation therapy (procedure)