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Alkylating agents

Combination Therapy for Brain Tumor

Phase 3

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years after tumor cell analysis in 122 participants

Awards & highlights

Study Summary

This trial is looking at two different radiation therapy regimens in combination with chemotherapy and autologous stem cell transplant to treat patients with newly diagnosed medulloblastoma, supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.

Eligible Conditions

Brain Tumor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years after tumor cell analysis in 122 participants

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years after tumor cell analysis in 122 participants

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after tumor cell analysis in 122 participants for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency of Mutations Associated With SHH and WNT Tumors

Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.

Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors

Secondary outcome measures

Associative Memory for Two Risk Group at 5 Years After Enrollment

Associative Memory for Two Risk Group at Enrollment

Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa

+5 more

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597

44%

Acute RT Toxicity: Bowel: NOS

29%

Hormone Toxicity: Hot flashes : NOS

26%

Late RT Toxicity: Bowel: NOS

24%

Hormone Toxicity: Impotence : NOS

18%

Late RT Toxicity: Bladder: NOS

17%

Hormone Toxicity: Hematologic : NOS

15%

Acute RT Toxicity: Bladder: NOS

13%

Acute RT Toxicity: Hematologic: NOS

13%

Late RT Toxicity: Hematologic: NOS

13%

Acute RT Toxicity: Other: NOS

Hormone Toxicity: Liver : NOS

Late RT Toxicity: Other: NOS

Late RT Toxicity: Other GU: NOS

100%

80%

60%

40%

20%

Study treatment Arm

Neoadjuvant TAS 2 Months Before and During RT

Radiation Therapy Alone

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stratum 2 (average-risk group)Experimental Treatment6 Interventions

Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy

Group II: Stratum 1 (high-risk group)Experimental Treatment6 Interventions

Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

filgrastim

1997

Completed Phase 3

~7260

cyclophosphamide

1994

Completed Phase 3

~8140

cisplatin

1997

Completed Phase 3

~3290

autologous hematopoietic stem cell transplantation

2003

Completed Phase 3

~1990

radiation therapy

1994

Completed Phase 3

~13390

vincristine

2005

Completed Phase 4

~3840

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,306,161 Total Patients Enrolled

Amar Gajjar, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

9 Previous Clinical Trials

2,173 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00085202 — Phase 3

Brain Tumor Research Study Groups: Stratum 2 (average-risk group), Stratum 1 (high-risk group)

Brain Tumor Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00085202 — Phase 3

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00085202 — Phase 3

Frequently Asked Questions

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

How is radiation therapy most often utilized?

"Radiation therapy is the standard treatment for advanced testicular cancer, but it can also be used to effectively treat other conditions like small cell lung cancer, multiple sclerosis, and acute myelocytic leukemia."

Answered by AI

Are there long-term effects of radiation therapy on patients?

"Radiation therapy received a score of 3 from our analysts because it is a Phase 3 trial, meaning that there is some data showing that it is effective and multiple rounds of data supporting safety."

Answered by AI

Is this research project being conducted in multiple states?

"In addition to other locations, this research is being conducted with children at the Children's Hospital of Philadelphia in Pennsylvania, the Hospital for Sick Children in Toronto, Ontario, and the Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital in Houston, Texas."

Answered by AI

If I am interested in enrolling, what is the process?

"Currently, this study is not enrolling new patients. The study was originally posted on August 1st, 2003, with the most recent edit on December 17th, 2021. There are 1631 other studies actively recruiting patients for radiation therapy and 195 for central nervous system neoplasms."

Answered by AI

How many individuals are able to join this clinical research?

"This study is no longer recruiting patients for the trial. The original posting date was 8/1/2003, with the most recent edit on 12/17/2021. However, there are other opportunities available; as of now, there are 1631 radiation therapy studies and 195 central nervous system neoplasms studies that are actively recruiting patients."

Answered by AI

How does this radiation therapy clinical trial compare to others that have been completed?

"City of Hope Comprehensive Cancer Center first began studying radiation therapy in 1997 and, as of now, 2504 completed studies later, there is a growing body of evidence. There are 1631 clinical trials currently underway, with a large portion of these taking place in the city of Philadelphia, Pennsylvania."

Answered by AI

Are people over the age of 45 able to sign up for this experiment?

"According to the eligibility requirements listed, patients must be between the ages of 3 to 21 to participate. Out of the 5118 clinical trials currently underway, 518 are for people under the age of 18 and 1421 are for people over the age of 65."

Answered by AI

What are the goals for this particular medical study?

"The primary goal of this clinical trial is to evaluate the frequency of mutations associated with SHH and WNT tumors over a 2-year period in 122 participants. Secondary outcomes include mean RT dose to specified target tissue volume by rate and pattern of failure, reading decoding composite scores in the intervention and standard of care groups, and number of average risk patients whose treatment failure included the posterior fossa."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Outcomes by Clinical and Molecular Features in Children with Medulloblastoma Treated with Risk-adapted Therapy: Results of an International Phase III Trial (SJMB03)

Gajjar, Amar, Giles W. Robinson, Kyle S. Smith, Tong Lin, Thomas E. Merchant, Murali Chintagumpala, Anita Mahajan, et al.. 2021. “Outcomes by Clinical and Molecular Features in Children with Medulloblastoma Treated with Risk-adapted Therapy: Results of an International Phase III Trial (SJMB03)”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01372.

Nature GeneticsJournal

Common Variants in ACYP2 Influence Susceptibility to Cisplatin-induced Hearing Loss

Xu, Heng, Giles W Robinson, Jie Huang, Joshua Yew-Suang Lim, Hui Zhang, Johnnie K Bass, Alberto Broniscer, et al.. 2015. “Common Variants in ACYP2 Influence Susceptibility to Cisplatin-induced Hearing Loss”. Nature Genetics. Springer Science and Business Media LLC. doi:10.1038/ng.3217.

Journal of Clinical OncologyJournal

Clinical Outcomes and Patient-matched Molecular Composition of Relapsed Medulloblastoma

Kumar, Rahul, Kyle S. Smith, Maximilian Deng, Colt Terhune, Giles W. Robinson, Brent A. Orr, Anthony P. Y. Liu, et al.. 2021. “Clinical Outcomes and Patient-matched Molecular Composition of Relapsed Medulloblastoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.20.01359.

European Journal of CancerJournal