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Cancer Vaccine

SurVaxM Vaccine for Brain Cancer

Phase 1
Recruiting
Research Sponsored by Pediatric Brain Tumor Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined as tumors with a pontine epicenter and diffuse involvement of 2/3 or more of the pons, are eligible without histologic confirmation and will proceed directly to enrollment without screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years from treatment initiation
Awards & highlights

Study Summary

This trial is testing a vaccine (SurVaxM) that helps the body's immune system destroy cells that express a protein called survivin (found in up to 95% of glioblastomas and other types of cancer). The vaccine is given with Montanide ISA 51 (to create a stronger immune response) and sargramostim (to stimulate the immune system). Priming Phase: 1 dose every 2 weeks for 6 weeks. Maintenance Phase: 1 dose every 8 weeks for up to 2 years.

Who is the study for?
This trial is for children and young adults aged 1 to 21 with specific brain tumors (like medulloblastoma, high-grade glioma, ependymoma) that are progressive or relapsed. They must have completed prior treatments without severe side effects, be HIV-negative or well-controlled on therapy, and have good organ function. Participants need to agree to use birth control and provide consent.Check my eligibility
What is being tested?
The study tests SurVaxM vaccine combined with Montanide ISA 51 in two phases: Priming (4 doses every 2 weeks) and Maintenance (doses every 8 weeks up to two years). It aims to train the immune system to attack tumor cells expressing survivin protein. Sargramostim is also given to boost the immune response.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, muscle aches, possible allergic reactions due to KLH content in SurVaxM or sargramostim components. Long-term follow-up will monitor for any delayed side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hepatitis B virus load is undetectable with treatment.
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I have a newly diagnosed brain tumor in the pons without needing a biopsy.
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My cancer can be measured or seen on tests.
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My tumor shows at least 1% survivin expression, confirmed by a test at RPCCC.
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I received my last cancer treatment affecting bone marrow over 21 days ago, or over 42 days ago if it was a specific type.
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I am HIV positive, on effective treatment, and my viral load has been undetectable for 6 months.
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I finished my radiation for DIPG between 2 to 8 weeks ago and my cancer hasn't worsened.
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I am between 1 and 21 years old.
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I have recovered from side effects of my last antibody treatment, taken over 28 days ago.
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I do not have a bleeding disorder nor am I on blood thinners.
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I finished my radiation therapy between 2 to 8 weeks ago and haven't had other cancer treatments since.
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My brain tumor is growing or has returned after standard treatment.
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My brain tumor is confirmed as GBM or Grade II/III astrocytoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years from treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years from treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects with Pseudoprogression Related Regimen-Limiting Toxicity
Percentage of Subjects with Regimen-Limiting Toxicity (RLT)
Secondary outcome measures
Differences in MR permeability and MR perfusion parameters for patients with true progression vs. pseudoprogression
Other outcome measures
Best Response Rate
Overall Survival
Progression Free Survival

Trial Design

3Treatment groups
Experimental Treatment
Group I: SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 yearsExperimental Treatment1 Intervention
500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg. Priming Phase: patients will get one dose of SurVaxM combined with Montanide ISA 51 through a subcutaneous injection at the start of the study and every 2 weeks for 6 weeks (for a total of 4 doses). At each SurVaxM/Montanide ISA 51 injection, patients will also get an injection of sargramostim. Maintenance Phase: the patient will get a SurVaxM/Montanide ISA 51 dose along with a sargramostim dose about every 8 weeks for up to two years. After finishing study treatment, patients will be followed for up to 3 years following the last dose of SurVaxM/Montanide ISA 51. Patients will be followed in clinic every 3 months during the follow-up.
Group II: SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 yearsExperimental Treatment1 Intervention
500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg. Priming Phase: patients will get one dose of SurVaxM combined with Montanide ISA 51 through a subcutaneous injection at the start of the study and every 2 weeks for 6 weeks (for a total of 4 doses). At each SurVaxM/Montanide ISA 51 injection, patients will also get an injection of sargramostim. Maintenance Phase: the patient will get a SurVaxM/Montanide ISA 51 dose along with a sargramostim dose about every 8 weeks for up to two years. After finishing study treatment, patients will be followed for up to 3 years following the last dose of SurVaxM/Montanide ISA 51. Patients will be followed in clinic every 3 months during the follow-up.
Group III: SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 yearsExperimental Treatment1 Intervention
500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg. Priming Phase: patients will get one dose of SurVaxM combined with Montanide ISA 51 through a subcutaneous injection at the start of the study and every 2 weeks for 6 weeks (for a total of 4 doses). At each SurVaxM/Montanide ISA 51 injection, patients will also get an injection of sargramostim. Maintenance Phase: the patient will get a SurVaxM/Montanide ISA 51 dose along with a sargramostim dose about every 8 weeks for up to two years. After finishing study treatment, patients will be followed for up to 3 years following the last dose of SurVaxM/Montanide ISA 51. Patients will be followed in clinic every 3 months during the follow-up.

Find a Location

Who is running the clinical trial?

American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN
8 Previous Clinical Trials
650 Total Patients Enrolled
4 Trials studying Ependymoma
462 Patients Enrolled for Ependymoma
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,970 Total Patients Enrolled
81 Trials studying Ependymoma
8,845 Patients Enrolled for Ependymoma
Pediatric Brain Tumor ConsortiumLead Sponsor
37 Previous Clinical Trials
1,547 Total Patients Enrolled
7 Trials studying Ependymoma
589 Patients Enrolled for Ependymoma

Media Library

SurVaxM (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04978727 — Phase 1
Ependymoma Research Study Groups: SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 years, SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 years, SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 years
Ependymoma Clinical Trial 2023: SurVaxM Highlights & Side Effects. Trial Name: NCT04978727 — Phase 1
SurVaxM (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04978727 — Phase 1

Frequently Asked Questions

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

Are there any potential risks associated with SurVaxM treatments for children and young adults between the ages of 10-21 years old who have suffered a recurrence or progression of MB, HGG or ependymoma?

"Due to the preliminary nature of this Phase 1 trial, SurVaxM has been assessed as having a safety rating of 1 when used in children between the ages of 10 and 21 suffering from relapsed or progressive MB, HGG or ependymoma."

Answered by AI

Who is eligible to take part in this investigation?

"To meet the criteria of this medical trial, patients must have diffuse intrinsic pontine glioma and be between 1 Year and 21 Years of age. A total of 35 individuals are being invited to take part in the study."

Answered by AI

Is the eligibility criteria for this experiment confined to adults aged twenty-five and over?

"Those wishing to participate in this medical trial must be aged between 1 year and 21 years old. There are 207 trials targeting those under 18, while 609 studies seek out seniors over 65."

Answered by AI

How many medical establishments are currently administering this research?

"The research team is currently enrolling patients from 4 facilities, situated in Pittsburgh, Cincinnati and Buffalo as well as other nearby areas. To reduce travel costs and effort, it's recommended to choose the nearest site if you decide to take part."

Answered by AI

Are there still vacancies for participants in this investigation?

"As displayed on clinicaltrials.gov, the recruitment process for this research study is in progress; it was initially announced on February 11th 2022 and recently updated as of August 30th 2022."

Answered by AI

To what extent is enrollment in this clinical trial being accepted?

"Affirmative. The clinical trial registry notes that this experiment commenced on February 11th 2022, and is currently recruiting participants. The study requires 35 individuals to join from 4 distinct sites."

Answered by AI

Who else is applying?

What site did they apply to?
Ann and Robert H. Lurie Children's Hospital of Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

My son was recently diagnosed with a recurrent anaplastic ependymoma after 3.5 years NED. His care team is not recommending surgery so we are exploring any alternatives.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma
2022. "A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978727.
All > Glioblastoma Long Beach > Oligodendroglioma
~15 spots leftby Aug 2025
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