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

Completed · Phase 3

Conditions studied: Childhood Atypical Teratoid/Rhabdoid Tumor

In brief

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.

Key facts

Study ID

NCT00653068

Run by

Children's Oncology Group

People needed

70

Starts

2009-02-10

Expected to finish

2024-03-31

Last updated by the study team

2024-04-23

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lee Memorial Health System — Fort Myers, Florida, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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