Td vaccine for Brain Stem Glioma

UF Health Shands Children's Hospital, Gainesville, FL
Brain Stem Glioma+1 More ConditionsTd vaccine - Drug
Eligibility
3 - 30
All Sexes

Study Summary

This trial is testing whether adding immunotherapy to radiotherapy and temozolomide helps children with DIPG.

Eligible Conditions
  • Brain Stem Glioma
  • Diffuse Intrinsic Pontine Glioma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Day 30
Feasibility and safety of adoptive cellular therapy in pediatric patients with DIPG with or without dose-intensified TMZ during cycles of DC vaccination
Day 14
Determine the maximally achievable dose (MAD) or maximum tolerated dose (MTD) of xALT plus DC and HSC in Group A and Group B subjects
Up to 10 months
Post-immunotherapy functional anti-tumor immune responses
Up to 5 years
Analysis of overall survival (OS)
Analysis of progression-free survival (PFS)

Trial Safety

Phase-Based Safety

1 of 3

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1
SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 years
1
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1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2 Treatment Groups

Group A
1 of 2
Group B
1 of 2

Experimental Treatment

21 Total Participants · 2 Treatment Groups

Primary Treatment: Td vaccine · No Placebo Group · Phase 1

Group AExperimental Group · 5 Interventions: TTRNA-DC vaccines with GM-CSF, TTRNA-xALT, Td vaccine, Autologous Hematopoietic Stem Cells (HSC), Dose-Intensified TMZ · Intervention Types: Biological, Biological, Drug, Biological, Drug
Group BExperimental Group · 5 Interventions: TTRNA-DC vaccines with GM-CSF, TTRNA-xALT, Td vaccine, Cyclophosphamide + Fludarabine Lymphodepletive Conditioning, Autologous Hematopoietic Stem Cells (HSC) · Intervention Types: Biological, Biological, Drug, Drug, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

University of FloridaLead Sponsor
1,274 Previous Clinical Trials
700,016 Total Patients Enrolled
Accelerate Brain Cancer CureOTHER
3 Previous Clinical Trials
330 Total Patients Enrolled
Lyla Nsouli FoundationUNKNOWN
Sridharan Gururangan, MDPrincipal InvestigatorUniversity of Florida
Elias Sayour, MD, PhDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
38 Total Patients Enrolled

Eligibility Criteria

Age 3 - 30 · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Who is qualified to partake in the trial?

"21 individuals with brain stem gliomas aged 3 to 30 are welcomed as part of this trial. Critically, potential participants must consent to a biopsy for diagnostic purposes and RNA extraction, maintain platelets above 100K/µl (unsupported), and have an ANC ≥ 1000/µl (unsupported). Furthermore, KPS or LPS must be > 50% within two weeks prior to enrollment." - Anonymous Online Contributor

Unverified Answer

Is elderly eligibility being considered for this medical experiment?

"This trial is inviting applicants between the ages of 3 and 30 to join." - Anonymous Online Contributor

Unverified Answer

What endemic or epidemic diseases is the Td vaccine commonly employed against?

"Td vaccine is the standard treatment for multiple sclerosis and has shown to be efficacious at treating additional medical conditions like mixed-cell type lymphoma, myelocytic leukemia, acute forms of leukemia, as well as retinoblastoma." - Anonymous Online Contributor

Unverified Answer

How many individuals are currently enrolled in this trial?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research project, which was originally published on May 17th 2018, is presently searching for willing participants. 21 individuals must be enrolled from one medical facility." - Anonymous Online Contributor

Unverified Answer

Are there current opportunities for patients to participate in this clinical investigation?

"According to clinicaltrials.gov, this drug trial is actively seeking patients. The initial post was on 17th May 2018 with the most recent update being 22nd August 2022." - Anonymous Online Contributor

Unverified Answer

Are there any other existing studies that focus on the efficacy of Td vaccine?

"Presently, there is a massive body of clinical trials researching the Td vaccine. Of these 889 active studies, 161 have progressed to Phase 3. While several are based in Philadelphia, Pennsylvania; across 28443 locations worldwide scientists and clinicians study this potential treatment." - Anonymous Online Contributor

Unverified Answer

Has the Td vaccine been authorized by the FDA?

"This vaccine has yet to be fully evaluated, so it was given a score of 1 in terms of safety. This is because this particular trial is only at the initial stages, where there exist limited data on its efficacy and safety." - 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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