Aerobic Training for Medulloblastoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
St. Jude Children's Research Hospital, Memphis, TN
Medulloblastoma
Aerobic Training - Other
Eligibility
< 65
All Sexes
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Study Summary

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

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Aerobic Training will improve 5 primary outcomes and 52 secondary outcomes in patients with Medulloblastoma. Measurement will happen over the course of baseline and 12 weeks post-randomization.

Month 10
Percentage of Participants Who Complete Pemetrexed and Gemcitabine Therapy
Year 5
Number of Local Failures
2 years after diagnosis
Overall Survival in Stratum N1
Overall Survival in Stratum N2
Overall Survival in Stratum N3
Overall Survival in Stratum S1 Skeletally Immature Cohort
Overall Survival in Stratum S1 Skeletally Mature Cohort
Overall Survival in Stratum S2 Skeletally Immature Cohort
Overall Survival in Stratum S2 Skeletally Mature Cohort
Overall Survival in Stratum W1
Progression-free Survival in Stratum N1
Progression-free Survival in Stratum N1 Compared to Historical Controls
Progression-free Survival in Stratum N2
Progression-free Survival in Stratum N3
Progression-free Survival in Stratum S1 Skeletally Immature Cohort
Progression-free Survival in Stratum S1 Skeletally Mature Cohort
Progression-free Survival in Stratum S2 Skeletally Immature Cohort
Progression-free Survival in Stratum S2 Skeletally Mature Cohort
Progression-free Survival in Stratum W1
Progression-free Survival in Stratum W1 Compared to Historical Controls
Month 20
Percentage of Participants Who Complete Vismodegib Therapy
Month 10
Change in measure of attention between participants who received computer-based intervention VS. those who did not
Change in measure of executive function between participants who received computer-based intervention VS. those who did not
Change in measure of processing speed between participants who received computer-based intervention VS. those who did not
Change in measure of working memory between participants who received computer-based intervention VS. those who did not
Month 10
Change in measure of attention
Change in measure of executive function ability
Change in measure of processing speed
Week 40
Change in executive function score
Change in measure of memory function
Year 5
Change in fatigue score
Change in hand grip strength
Change in motor proficiency
Change in overall flexibility
Change in quality of life (QOL) score
Change in range of motion
Week 12
Change in sleep
Month 10
Association between baseline cognitive performance and fatigue
Association between baseline cognitive performance and sleep quality
Association between baseline cognitive performance and sleep quantity
Month 3
Change in measure of attention among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone)
Change in measure of executive function among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone)
Change in measure of processing speed among 3 groups (working memory intervention + physical exercise intervention VS. working memory intervention alone VS. physical training intervention alone)
Year 5
Association of demographic and clinical factors with change in academic ability
Association of demographic and clinical factors with change in attention
Association of demographic and clinical factors with change in cognitive processing speed
Association of demographic and clinical factors with change in intellectual function
Association of demographic and clinical factors with change in memory
Association of demographic and clinical factors with change in neurocognitive executive function
Longitudinal change in measure of academic ability
Longitudinal change in measure of attention
Longitudinal change in measure of cognitive processing speed function
Longitudinal change in measure of intellectual function
Longitudinal change in measure of memory
Longitudinal change in measure of neurocognitive executive function
Week 12
Change in Spatial Span Backward Standard Score
Week 12
Change in VO2 Peak Value

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

8 Treatment Groups

Stratum N2: Intermediate Risk
1 of 8
Stratum S2: High Risk
1 of 8
Stratum S1: Standard Risk
1 of 8
Stratum N1: Standard Risk
1 of 8
Stratum W1: Low Risk
1 of 8
Stratum W2: Atypical
1 of 8
Stratum W3: High Risk
1 of 8
Stratum N3: High Risk
1 of 8
Experimental Treatment

This trial requires 660 total participants across 8 different treatment groups

This trial involves 8 different treatments. Aerobic Training is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Stratum N2: Intermediate RiskParticipants 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.
Stratum S2: High RiskParticipants 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.
Stratum S1: Standard RiskParticipants 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.
Stratum N1: Standard RiskParticipants 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.
Stratum W1: Low RiskParticipants 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.
Stratum W2: AtypicalParticipants 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.
Stratum W3: High RiskParticipants 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.
Stratum N3: High RiskParticipants 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Vismodegib
FDA approved
Gemcitabine
FDA approved
Cyclophosphamide
FDA approved
Cisplatin
FDA approved
Vincristine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and at 3 months after baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and at 3 months after baseline for reporting.

Closest Location

St. Jude Children's Research Hospital - Memphis, TN

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Medulloblastoma. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Medulloblastoma or medulloblastoma variants including posterior fossa PNET as documented by an institutional pathologist.
Participant's age meets one of the following: (1) Age greater than or equal to 3 years and less than 22 years of age at the time of diagnosis (may enroll on Strata W, S or N), OR (2) age is greater than or equal to 22 years and less than 40 years AND patient has SHH medulloblastoma (must enroll on Stratum S).
No previous radiotherapy, chemotherapy or other brain tumor directed therapy other than corticosteroid therapy and surgery.
Patients must begin treatment as outlined in the protocol within 36 days of definitive surgery (day of surgery is day 0; definitive surgery includes second surgeries to resect residual tumor).
Adequate performance status: children < 10-Lansky Score ≥ 30; children ≥ 10-Karnofsky ≥ 30 (except for posterior fossa syndrome).
Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants > 10 years of age or post-menarche must have a negative serum or urine pregnancy test prior to enrollment.
Biological parent(s) of participant (child) enrolling on this protocol. These parents will be assigned to cohort P. The

Patient Q&A Section

What causes medulloblastoma?

"The risk of getting medulloblastoma increases with a family history of cancer, having a sibling with a cancer diagnoses, previous maternal cancer at a young age, and having a first-born child that has tumours such as leukemia, glioblastoma multiforme or rhabdomyosarcoma. Exposure to ionising radiation and tobacco smoking before birth are also risk factors." - Anonymous Online Contributor

Unverified Answer

Can medulloblastoma be cured?

"There is currently insufficient clinical evidence to show a cure potential for m-B cell lymphoma. The development of specific targeted treatment in selected patients may allow a substantial change in long-term prognosis for this disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for medulloblastoma?

"Many patients with medulloblastoma require extensive surgery, radiation and chemotherapy. There are no cures for the disease. There are several types of chemotherapy available, including standard doses of cisplatin and newer drugs such as carboplatin. Other potentially curative treatments for medulloblastoma include high-intensity conditioning regimens followed by autologous stem cell transplantation or high-dose chemotherapy followed by autologous stem cell transplantation. Autologous stem cell transplantation has been done for patients with advanced tumors and is being explored as a potentially curative option for patients with earlier diagnoses of medulloblastoma." - Anonymous Online Contributor

Unverified Answer

What are the signs of medulloblastoma?

"Patients with medulloblastoma present with a variety of signs and symptoms. Although headache is common in patients with medulloblastoma, the most common presenting symptom is brain swelling due to mass effect. There may be a correlation between increased intracranial pressure and the presence of brain metastases. Although leukemia is considered an important risk factor for medulloblastoma, in our experience, headache is not a risk factor." - Anonymous Online Contributor

Unverified Answer

What is medulloblastoma?

"There are two types of medulloblastoma: sporadic medulloblastoma and neurofibromatosis type 1 medulloblastoma. Both types arise from primitive neuroectodermal cells that have lost normal differentiation processes during embryogenesis, resulting in the formation of tumors from undifferentiated cerebellar tissue. The clinical features, prognosis and response to treatment differ for the two types of medulloblastoma. In children with neurofibromatosis type 1 medulloblastoma and metastatic medulloblastoma, there are significant differences in survival rate and response to treatment compared with those with sporadic tumors from a similar grade and stage of disease." - Anonymous Online Contributor

Unverified Answer

How many people get medulloblastoma a year in the United States?

"Around 3,500 children in the US are diagnosed with medulloblastoma each year, making it the second most common cancer in children in the United States and the second most common cause of childhood cancer-related mortality. In the United Kingdom, medulloblastoma made up 8.510 in children under 15 years of age and 20.810 in children aged 15 to 19 years in 1984. This number was almost 10-fold greater in children under 15-years-old and nearly 20-fold in those aged 15-39. In the US, children under the age of 10 were 2." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in craniospinal irradiation with boost to the primary tumor site for therapeutic use?

"Combined high-dose-rate brachytherapy and radiation boost are safe and effective alternatives to standard radiation intensification schedule for treating primary CNS tumors to reduce both acute and late effects of CNS radiation to minimize treatment-related complications. Because of potential benefits including reduced acute toxicity and neurocognitive outcomes, these techniques could become the standard-of-care therapy for patients with medically inoperable primary CNS tumors." - Anonymous Online Contributor

Unverified Answer

Has craniospinal irradiation with boost to the primary tumor site proven to be more effective than a placebo?

"In this analysis, it was demonstrated that the addition of primary c-kit pathway inhibitors to c-kit-targeting treatments might decrease the incidence of cns-is, particularly of CNS-related tumor recurrences. This promising regimen warrants validation in a randomized controlled trial." - Anonymous Online Contributor

Unverified Answer

Does medulloblastoma run in families?

"Although the incidence of medulloblastoma continues to increase among black children in the United States, there is no increased risk of medulloblastoma among children of other races." - Anonymous Online Contributor

Unverified Answer

What is the latest research for medulloblastoma?

"The most recent trials reported in this database have confirmed the role of [chemotherapy plus the addition and maintenance of a new CNS site of consolidation] in the treatment of children with medulloblastoma. Further clinical trials are required. Trial registration. Trials registration. com." - Anonymous Online Contributor

Unverified Answer

What does craniospinal irradiation with boost to the primary tumor site usually treat?

"CSI is an important treatment for children with high-risk medulloblastoma regardless of other chemotherapy regimens. CSI alone improves event-free survival and decreases the rate of children with poor outcome at 5 years, even in those with only a single high-risk factor." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of medulloblastoma?

"Findings from a recent study demonstrates high frequency of mutations in TP53 but also in NTRK3. This is the first study to suggest a direct link between NTRK3 mutations, which are frequently observed in medulloblastomas, and high level TP53 mutation in the development of this neoplasm. As a new, independent marker, NTRK3 could help to identify patients at risk to have poorer prognosis and to guide further intensive treatment approaches." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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