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Combination Therapy for Rhabdoid Tumor

Phase 3

Waitlist Available

Led By Alyssa Reddy

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

No evidence of dyspnea at rest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during and after completion of study treatment up to 1 year after enrollment.

Awards & highlights

Study Summary

This trial is testing a combination of chemotherapy, radiation therapy, and stem cell transplant to treat atypical teratoid/rhabdoid tumor of the central nervous system in young patients.

Who is the study for?

This trial is for young patients with a rare brain tumor called atypical teratoid/rhabdoid tumor, or those with INI1 gene mutation. They should have no extra neural metastasis, a life expectancy over 8 weeks, normal organ function tests, and not be pregnant. Patients must use contraception and have had surgery within the past month.Check my eligibility

What is being tested?

The study tests high-dose chemotherapy combined with radiation therapy followed by an autologous stem cell transplant to treat the cancer. It aims to see how well these treatments work together in stopping cancer growth by destroying or preventing division of cancer cells.See study design

What are the potential side effects?

Possible side effects include damage to bone marrow (leading to low blood counts), increased risk of infections due to weakened immune system, potential harm to organs from high-dose chemotherapy, fatigue from treatment regimen, and complications related to stem cell transplantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is diagnosed as AT/RT or has an INI1 gene mutation.

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I do not have trouble breathing when I am resting.

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My liver enzymes are within normal limits for my age.

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My bilirubin levels are within normal range for my age.

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I had or will have a brain MRI before and after using a contrast agent, close to my surgery date.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during protocol therapy up to 1 year after enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during protocol therapy up to 1 year after enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during protocol therapy up to 1 year after enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free Survival

Overall Survival (OS)

Toxic Death

Secondary outcome measures

Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (chemotherapy, 3D-CRT, autologous PBSC)Experimental Treatment12 Interventions

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.

Group II: Arm I (chemotherapy, autologous PBSC, 3D-CRT)Experimental Treatment12 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2013

Completed Phase 4

~3800

Cyclophosphamide

1995

Completed Phase 3

~3780

Filgrastim

2000

Completed Phase 3

~3670

Cisplatin

2013

Completed Phase 3

~1940

Leucovorin Calcium

2011

Completed Phase 3

~12290

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7160

Autologous Hematopoietic Stem Cell Transplantation

2017

Completed Phase 3

~1730

Thiotepa

2008

Completed Phase 3

~2150

Vincristine Sulfate

2005

Completed Phase 3

~10110

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,630 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,253 Total Patients Enrolled

2 Trials studying Atypical Teratoid/Rhabdoid Tumor

386 Patients Enrolled for Atypical Teratoid/Rhabdoid Tumor

Alyssa ReddyPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is 3-Dimensional Conformal Radiation Therapy a reliable cancer treatment?

"There is some data supporting the efficacy of 3-Dimensional Conformal Radiation Therapy, and it has undergone multiple rounds of testing to confirm its safety. Our team rates its safety as a 3."

Answered by AI

What does 3-Dimensional Conformal Radiation Therapy mostly help cure?

"3-Dimensional Conformal Radiation Therapy is an effective treatment method for patients with merkel cell cancer, leukemia, and those who are in the initial stages of treatment."

Answered by AI

Are there other instances where 3-Dimensional Conformal Radiation Therapy has been used?

"3DCRT was first studied in 1997 concerning its efficacy in cancer treatment. Since the initial study, there have been 4534 completed clinical trials. Additionally, there are 2490 active trials recruiting patients as we speak. A large number of these studies are based in New york City."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Reply to S.A. Upadhyaya

Reddy, Alyssa T., Mark D. Krailo, Allen B. Buxton, Douglas R. Strother, Annie Huang, Tianni Zhou, Alexander R. Judkins, et al.. 2020. “Reply to S.A. Upadhyaya”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01573.

clinicaltrials.govStudy

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

2008. "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. https://clinicaltrials.gov/ct2/show/NCT00653068.

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