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Platinum-based Chemotherapy

Risk-Directed Therapy for Medulloblastoma

Q: What conditions has Cisplatin demonstrated effectiveness in treating?

<p>Cisplatin is a common choice for targeting <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, but it also has applications in treating urinary <a href="https://www.withpower.com/clinical-trials/bladder-cancer">bladder cancer</a>, lung cancers and advanced testicular tumors.</p>

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

No previous radiotherapy, chemotherapy, or other brain tumor directed therapy other than corticosteroid therapy and surgery

Medulloblastoma or medulloblastoma variants including posterior fossa PNET as documented by an institutional pathologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at 3 months after baseline

Awards & highlights

Study Summary

This trial will use a new way to treat medulloblastoma, which is a cancer of the brain. The treatment will be based on the amount of leftover disease present after surgery, as well as the type of cancer cells. This will help to determine the best way to treat the cancer and improve the outcome for patients.

Who is the study for?

This trial is for individuals aged 3-22 with newly diagnosed medulloblastoma, or those up to age 40 with SHH subtype. They must have had surgery within the last 36 days and not received prior brain tumor treatments. Good performance status is required, and women of childbearing potential must not be pregnant.Check my eligibility

What is being tested?

The study tests a tailored treatment approach based on both clinical risk (low to high) and molecular subtype (WNT, SHH, Non-WNT/Non-SHH) of medulloblastoma. It involves varying doses of radiation and chemotherapy including cyclophosphamide, cisplatin, vincristine; targeted drugs like vismodegib; new agents pemetrexed, gemcitabine; plus supportive therapies such as aerobic training and neurocognitive remediation.See study design

What are the potential side effects?

Possible side effects include nausea from chemotherapy, hair loss due to radiation therapy, fatigue from treatment regimens, muscle weakness or numbness from vincristine. Newer drugs may cause unknown reactions while supportive therapies are generally well-tolerated.

Eligibility Criteria

Inclusion Criteria

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

Select...

I haven't had any treatment for my brain tumor except for steroids and surgery.

Select...

My cancer is a type of brain tumor known as medulloblastoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at 3 months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at 3 months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 3 months after baseline for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Spatial Span Backward Standard Score

Change in VO2 Peak Value

Progression-free Survival in Stratum N1

+2 more

Secondary outcome measures

Association between baseline cognitive performance and fatigue

Association between baseline cognitive performance and sleep quality

Association between baseline cognitive performance and sleep quantity

+49 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Ischaemic stroke

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

8Treatment groups

Experimental Treatment

Group I: Stratum W3: High RiskExperimental Treatment6 Interventions

Participants in stratum W3 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.

Group II: Stratum W2: AtypicalExperimental Treatment6 Interventions

Participants in stratum W2 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.

Group III: Stratum W1: Low RiskExperimental Treatment6 Interventions

Participants in stratum W1 will undergo reduced dose Craniospinal Irradiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.

Group IV: Stratum S2: High RiskExperimental Treatment7 Interventions

Participants in stratum S2 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. After completion of 4 cycles of chemotherapy, participants who are skeletally mature will receive maintenance chemotherapy with vismodegib. Some participants will complete aerobic training and/or neurocognitive remediation.

Group V: Stratum S1: Standard RiskExperimental Treatment7 Interventions

Participants in stratum S1 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. After completion of 4 cycles of chemotherapy, participants who are skeletally mature will receive maintenance chemotherapy with vismodegib. Some participants will complete aerobic training and/or neurocognitive remediation.

Group VI: Stratum N3: High RiskExperimental Treatment8 Interventions

Participants in stratum N3 will undergo high dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive standard chemotherapy (cisplatin, vincristine, cyclophosphamide) for 4 cycles intermixed with an additional 3 cycles of chemotherapy with pemetrexed and gemcitabine in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.

Group VII: Stratum N2: Intermediate RiskExperimental Treatment8 Interventions

Participants in stratum N2 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive standard chemotherapy (cisplatin, vincristine, cyclophosphamide) for 4 cycles intermixed with an additional 3 cycles of chemotherapy with pemetrexed and gemcitabine in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.

Group VIII: Stratum N1: Standard RiskExperimental Treatment6 Interventions

Participants in stratum N1 will undergo standard dose craniospinal radiation with boost to the primary tumor site once daily 5 days a week for 6 weeks. Six weeks after completion of radiotherapy, patients receive one cycle of chemotherapy (cisplatin, vincristine, cyclophosphamide) once every 4 weeks for 4 cycles in absence of unacceptable toxicity. Some participants will complete aerobic training and/or neurocognitive remediation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3780

Cisplatin

2013

Completed Phase 3

~1940

Vincristine

2003

Completed Phase 4

~2910

Vismodegib

2015

Completed Phase 4

~1880

Pemetrexed

2014

Completed Phase 3

~5250

Gemcitabine

2017

Completed Phase 3

~2070

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor

427 Previous Clinical Trials

5,305,917 Total Patients Enrolled

13 Trials studying Medulloblastoma

2,236 Patients Enrolled for Medulloblastoma

Genentech, Inc.Industry Sponsor

1,539 Previous Clinical Trials

567,029 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,493 Total Patients Enrolled

89 Trials studying Medulloblastoma

9,725 Patients Enrolled for Medulloblastoma

Media Library

Cisplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01878617 — Phase 2

Medulloblastoma Research Study Groups: Stratum W1: Low Risk, Stratum W2: Atypical, Stratum W3: High Risk, Stratum S1: Standard Risk, Stratum S2: High Risk, Stratum N1: Standard Risk, Stratum N2: Intermediate Risk, Stratum N3: High Risk

Medulloblastoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01878617 — Phase 2

Cisplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01878617 — Phase 2

Frequently Asked Questions

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

Am I eligible to join this research endeavor?

"This clinical trial is recruiting 660 pediatric and young adult patients with medulloblastoma. The age criteria must be met (ages 3 to 39) and females of child-bearing potential cannot be pregnant or breast-feeding, per protocol guidelines. Furthermore, eligible candidates should have undergone no prior radiotherapy, chemotherapy or other brain tumor directed therapy besides corticosteroid treatment and surgery; as well as present a sufficient performance status determined by the Lansky Score for children < 10 years old (<30) or Karnofsky score for those aged ≥10 (> 30). Lastly, biological parent(s) of participants enrolling on this study will"

Answered by AI

What is the total count of enrollees for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is currently in the process of enrolling participants. It was first posted on June 23, 2013 and updated most recently on May 13th 2022 with a goal of recruiting 660 patients at one site."

Answered by AI

Has the FDA validated Cisplatin for medical use?

"The safety of Cisplatin was rated a 2; while there are some reports outlining its security, no data exists yet to confirm the drug's efficacy."

Answered by AI

What conditions has Cisplatin demonstrated effectiveness in treating?

"Cisplatin is a common choice for targeting leukemia, but it also has applications in treating urinary bladder cancer, lung cancers and advanced testicular tumors."

Answered by AI

Does this experiment need any more volunteers?

"According to clinicaltrials.gov, this examination is currently recruiting participants and has been since June 23rd 2013, with the latest update occurring on May 13th 2022."

Answered by AI

Does this trial offer enrollment for seniors over the age of fifty-five?

"The patient parameters for the trial stipulate that those signing up are aged between 3 and 39. There are 437 studies specifically tailored to minors, as well as 1,628 trials crafted for seniors over 65 years of age."

Answered by AI

What are the foremost goals of this medical experiment?

"While active for about two years, this clinical trial primarily evaluates Progression-free Survival in Stratum N1. Secondary objectives include assessing the effects of an aerobic training intervention on overall flexibility via a "sit and reach test," evaluating health related Quality of Life (QoL) using PedsQL(TM) 4.0 Generic Core Scales and Brain tumor Module, as well as gauging fatigue levels through usage of the 18-item PedsQL(TM) Multidimensional Fatigue Scale."

Answered by AI

Recent research and studies

Neuro-OncologyJournal

Clinical Features, Neurologic Recovery, and Risk Factors of Postoperative Posterior Fossa Syndrome and Delayed Recovery: A Prospective Study

Khan, Raja B, Zoltan Patay, Paul Klimo Jr, Jie Huang, Rahul Kumar, Frederick A Boop, Darcy Raches, et al.. 2021. “Clinical Features, Neurologic Recovery, and Risk Factors of Postoperative Posterior Fossa Syndrome and Delayed Recovery: A Prospective Study”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noab030.

Neuro-OncologyJournal

Clinical Features, Neurologic Recovery, and Risk Factors of Postoperative Posterior Fossa Syndrome and Delayed Recovery: A Prospective Study

clinicaltrials.govStudy

A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

2013. "A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01878617.

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