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

Overview

About this study

This phase III trial is studying giving combination chemotherapy together with 3-dimensional conformal radiation therapy and an autologous peripheral blood stem cell transplant to see how well it works 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/μL
Platelet count > 100,000/μL (transfusion independent)
Hemoglobin > 8 g/dL (RBC transfusions allowed)
Creatinine clearance (minimum of 12-24 hour urine collection) or radioisotope GFR ≥ 60mL/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
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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Wendy Allen-Rhoades, M.D., Ph.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wendy Allen-Rhoades, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials