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Aurora Kinase Inhibitor
Alisertib for Rhabdoid Tumors (SJATRT Trial)
Phase 2
Waitlist Available
Led By Amar Gajjar, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic diagnosis of AT/RT or MRT with loss of INI1 or BRG1 expression in tumor cells confirmed by immunohistochemistry, or by molecular confirmation of tumor-specific biallelic SMARCB1/SMARCA4 loss/mutation if INI1/BRG1 immunohistochemistry is not available
Patients with newly diagnosed AT/RT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of tumor assessment (up to 5 years)
Awards & highlights
SJATRT Trial Summary
This trial will test the use of alisertib to treat patients younger than 22 years of age with recurrent or refractory atypical teratoid rhabdoid tumor (AT/RT) or malignant rhabdoid tumor (MRT). Alisertib will be given as a single agent or in combination with other therapy, depending on the patient's age and diagnosis. The trial will also test the use of alisertib in patients with newly diagnosed AT/RT, to see if it can help improve the 3-year progression-free survival rate.
Who is the study for?
This trial is for patients under 22 years old with rhabdoid tumors, including AT/RT or MRT. They must have a confirmed diagnosis and measurable disease or tumor cells in CSF. Participants need proper organ function, no prior alisertib treatment, and a life expectancy over 8 weeks. Females of childbearing age must test negative for pregnancy and agree to birth control use.Check my eligibility
What is being tested?
The study tests alisertib's effectiveness on pediatric patients with recurrent or newly diagnosed rhabdoid tumors. It will be given alone or with chemotherapy/radiation depending on the patient's condition and age. The trial aims to measure response rates, progression-free survival (PFS), overall survival (OS), drug toxicity, local/distant failure patterns, and pharmacokinetics.See study design
What are the potential side effects?
Possible side effects include toxicities related to alisertib when used as a single agent or combined with other therapies across multiple courses; these may affect organs like bone marrow, liver, kidneys etc., as well as potential radiation therapy-related toxicities.
SJATRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor lacks INI1 or BRG1, confirmed by tests.
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I have been recently diagnosed with AT/RT.
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I have been newly diagnosed with AT/RT and have cancer outside the brain.
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My cancer has returned or worsened and can be seen on scans.
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My kidney, liver, and bone marrow are functioning well.
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I was diagnosed before my 22nd birthday.
SJATRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of tumor assessment (up to 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of tumor assessment (up to 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year progression free survival rate (stratum B2)
1-year progression free survival rate (stratum C2)
3-year progression free survival rate (stratum B1)
+4 moreSecondary outcome measures
1-year progression-free survival (PFS) by stratum A1 and A2
5-year Overall survival (OS) rate in patients with newly diagnosed AT/RT (strata B1, B2, B3, C1, C2)
5-year Progression-free survival (PFS) rate in patients with newly diagnosed AT/RT (strata B1, B2, B3, C1, C2)
+2 moreSide effects data
From 2013 Phase 3 trial • 397 Patients • NCT0000405478%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Late RT Toxicity: Other: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Nausea
2%
Hyperglycemia NOS
2%
Depression NEC
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Stomatitis
1%
Platelet count decreased
1%
Blood albumin decreased
1%
Weight decreased
1%
Anorexia
1%
Hypocalcemia
1%
Hyponatremia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy
SJATRT Trial Design
3Treatment groups
Experimental Treatment
Group I: (C) Alisertib, chemotherapy, radiation therapyExperimental Treatment6 Interventions
Stratum C: Children ≥36 months old with newly diagnosed AT/RT.
Participants with synchronous extraneural AT/RT (Stratum D4) will also be treated as those assigned to Stratum C.
Interventions: Craniospinal radiation therapy; followed by consolidation chemotherapy using alisertib, vincristine, cisplatin (or carboplatin), cyclophosphamide; followed by maintenance alisertib, surgical resection, if indicated.
Group II: (B) Alisertib, chemotherapy, radiation therapyExperimental Treatment10 Interventions
Stratum B: Children < 36 months old with newly diagnosed AT/RT. AT/RT those with synchronous extraneural AT/RT (Stratum D1) may also be treated on this arm.
Interventions:
B1 or D1: Induction chemotherapy using methotrexate, vincristine, cisplatin (or carboplatin), cyclophosphamide; followed by focal radiation therapy; followed by induction therapy using alisertib, vincristine, cisplatin (or carboplatin), cyclophosphamide; followed by maintenance alisertib. Those <12 months who are not ready for focal radiation therapy will receive consolidation chemotherapy using alisertib, cyclophosphamide, carboplatin and etoposide while RT is delayed. Surgical resection, if indicated.
B2, B3, D2 or D3: Induction chemotherapy using alisertib, vincristine, cisplatin (or carboplatin), cyclophosphamide; followed by consolidation with topotecan and cyclophosphamide or optional craniospinal irradiation; followed by maintenance alisertib. Surgical resection, if indicated.
Group III: (A) Alisertib aloneExperimental Treatment2 Interventions
Stratum A: Patients with recurrent/progressive AT/RT or extra-CNS malignant rhabdoid tumors (MRT).
Interventions: alisertib, 35 cycles of 3 weeks each (up to 105 weeks). Surgical resection, if indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical resection
2021
Completed Phase 2
~920
Radiation therapy
2013
Completed Phase 3
~2850
alisertib
2013
Completed Phase 1
~110
methotrexate
1997
Completed Phase 3
~9960
cisplatin
1997
Completed Phase 3
~3290
carboplatin
2010
Completed Phase 3
~4790
cyclophosphamide
1994
Completed Phase 3
~8140
etoposide
1994
Completed Phase 3
~9300
topotecan
2009
Completed Phase 3
~870
vincristine
2005
Completed Phase 4
~3840
Find a Location
Who is running the clinical trial?
Takeda Pharmaceuticals U.S.A., Inc.UNKNOWN
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,789 Total Patients Enrolled
St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,452 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor lacks INI1 or BRG1, confirmed by tests.My neurological condition is stable, and I've been on a consistent dose of corticosteroids for over a week.I have been recently diagnosed with AT/RT.I am not pregnant or breastfeeding.I will start treatment within 42 days after my surgery.I have been newly diagnosed with AT/RT and have cancer outside the brain.I have not had a heart attack in the last 6 months and do not have severe heart failure.I am a female over 10 or have had my first period and have a negative pregnancy test.I currently have an infection that is not under control.I haven't taken any strong enzyme inducers in the last week.I agree to use birth control or abstain from sex during and for 12 months after treatment.My cancer has returned or worsened and can be seen on scans.I can care for myself but may not be able to do active work.I have recovered from the side effects of my previous cancer treatments.I do not have stomach or bowel problems that affect medication absorption.My kidney, liver, and bone marrow are functioning well.I need to take medication regularly for stomach acid or digestion.I have a condition causing excessive daytime sleepiness.I was diagnosed before my 22nd birthday.
Research Study Groups:
This trial has the following groups:- Group 1: (C) Alisertib, chemotherapy, radiation therapy
- Group 2: (A) Alisertib alone
- Group 3: (B) Alisertib, chemotherapy, radiation therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior experiments have been conducted utilizing Radiation therapy?
"Since 1997, radiation therapy has been the subject of 3399 clinical trials. Currently 2079 are underway, with many hosted at Orlando's City of Hope Comprehensive Cancer Center."
Answered by AI
How many participants are being enrolled to this research program?
"This medical experiment necessitates 180 qualified participants. These individuals may join the clinical trial at sites such as UF Cancer Center at Orlando Health in Florida or Rady Children's Hospital in California."
Answered by AI
What maladies are commonly treated with radiation therapy?
"Radiation therapy is widely used to tackle squamous cell carcinoma and other malignancies like refractory testicular cancer, lymphoma, and acute lymphoblastic leukemia."
Answered by AI
What potential adverse effects are associated with Radiation therapy?
"The safety of Radiation therapy was assessed by our team with a score of 2, since this phase two trial has evidence that it is safe but not yet effective."
Answered by AI
How many health facilities are conducting this research?
"Currently, 9 different clinical sites are managing the trial including UF Cancer Center at Orlando Health in Florida, Rady Children's Hospital of San Diego and Washington DC's Children's National Medical Centre. Additional medical centres are also engaged with this research endeavour."
Answered by AI
Are there any opportunities to participate in this investigation currently available?
"Clinicaltrials.gov reveals that recruitment for this clinical trial is currently underway; it was initially posted on May 14th 2014, with the most recent update taking place August 1st 2022."
Answered by AI
What is the primary aim of this research?
"According to the trial sponsor, Millennium Pharmaceuticals, Inc., their primary outcome of interest is gauging sustained response rate among pediatric participants with recurrent or refractory MRT treated with alisertib (stratum A2). In addition, they will also be studying secondary outcomes such as 1-year progression-free survival (PFS) by strata A1 and A2, 5-year PFS rates in patients newly diagnosed AT/RT (strata B1, B2, B3 ,C1 and C2), and five year overall survival rates in similar patient groups."
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