SurVaxM Vaccine for Brain Cancer
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Pediatric Brain Tumor Consortium
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests the SurVaxM vaccine, which helps the immune system target and destroy cancer cells, in children and young adults with certain difficult-to-treat brain cancers. The vaccine works by teaching the immune system to recognize a protein found in cancer cells. Additional substances are used to make the immune response stronger.
What safety data is available for the SurVaxM vaccine for brain cancer?The SurVaxM vaccine has been evaluated in clinical studies for safety. In a Phase IIa study for newly diagnosed glioblastoma, SurVaxM was administered with adjuvant temozolomide and was part of a trial assessing safety, immunologic effects, and survival. Another clinical study on recurrent malignant glioma patients reported that SurVaxM was well tolerated, with mostly grade one adverse events and no serious adverse events attributable to the vaccine. Common side effects included local injection site reactions, fatigue, and myalgia. The vaccine also demonstrated immunogenicity, with patients developing cellular and humoral immune responses.12356
Is the SurVaxM treatment for brain cancer promising?Yes, the SurVaxM treatment for brain cancer is promising because it activates the immune system to fight cancer cells, has been well tolerated by patients, and has shown positive results in clinical trials, such as improved survival rates and stable disease in some patients.12356
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any other anti-cancer or investigational drug therapy, cannabidiol (CBD), medical marijuana, or immunosuppressive therapy at the time of enrollment. You also cannot have received a live vaccine within 30 days or an inactivated virus, peptide, or mRNA vaccine within 14 days of starting the trial. Please discuss your specific medications with the study team to ensure eligibility.
What data supports the idea that SurVaxM Vaccine for Brain Cancer is an effective treatment?The available research shows that SurVaxM, when used with the standard chemotherapy drug temozolomide, has shown promising results for patients with newly diagnosed glioblastoma. In a study, patients who received SurVaxM had a median overall survival of 86.6 weeks, with most patients surviving more than 12 months. Additionally, the vaccine was well tolerated, with only mild side effects reported. Compared to another treatment, DCVax-L, which showed a median overall survival of 19.3 months for newly diagnosed patients, SurVaxM also demonstrates potential as an effective treatment option.24567
Eligibility Criteria
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.Inclusion Criteria
My hepatitis B virus load is undetectable with treatment.
I have a newly diagnosed brain tumor in the pons without needing a biopsy.
My cancer can be measured or seen on tests.
My tumor shows at least 1% survivin expression, confirmed by a test at RPCCC.
I received my last cancer treatment affecting bone marrow over 21 days ago, or over 42 days ago if it was a specific type.
I am HIV positive, on effective treatment, and my viral load has been undetectable for 6 months.
I finished my radiation for DIPG between 2 to 8 weeks ago and my cancer hasn't worsened.
I am between 1 and 21 years old.
I have recovered from side effects of my last antibody treatment, taken over 28 days ago.
I do not have a bleeding disorder nor am I on blood thinners.
I finished my radiation therapy between 2 to 8 weeks ago and haven't had other cancer treatments since.
My brain tumor is growing or has returned after standard treatment.
My brain tumor is confirmed as GBM or Grade II/III astrocytoma.
Exclusion Criteria
I have had a condition where my lymphocytes grow abnormally.
I do not have an active infection needing treatment.
I am willing and able to follow the study's required visits, tests, and treatment plan.
I have or had lung inflammation or significant lung disease.
I am currently using CBD or medical marijuana.
My brain tumor is not in the pons or brainstem and is classified as Grade I or II.
I have a history of cancer.
My brain tumor has returned or gotten worse.
I am not currently on any cancer treatment or experimental drugs.
I have an active autoimmune disease or a history of one that needs ongoing treatment.
I have been diagnosed with Grade I myxopapillary ependymoma.
I am currently on immunosuppressive therapy, including corticosteroids.
My cancer originated in my spinal cord.
Treatment Details
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.
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.
SurVaxM is already approved in United States for the following indications:
🇺🇸 Approved in United States as SurVaxM for:
- None approved yet; under investigation for glioblastoma, malignant gliomas, neuroendocrine tumors, multiple myeloma, medulloblastoma, high-grade glioma, ependymoma, and diffuse intrinsic pontine glioma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Children's Healthcare of AtlantaAtlanta, GA
Hospital for Sick ChildrenToronto, Canada
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, CA
Texas Children's HospitalHouston, TX
More Trial Locations
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Who is running the clinical trial?
Pediatric Brain Tumor ConsortiumLead Sponsor
American Lebanese Syrian Associated Charities (ALSAC)Collaborator
National Cancer Institute (NCI)Collaborator
American Lebanese Syrian Associated CharitiesCollaborator
Roswell Park Cancer InstituteCollaborator
References
DCVax-Brain and DC vaccines in the treatment of GBM. [2019]DCVax-Brain (Northwest Biotherapeutics, Inc., Bethesda, MD, USA) is a personalized treatment for brain tumors. Its approach of administering autologous tumor antigen-bearing dendritic cells (DCs) has garnered hope for more effective and less toxic therapy for patients with malignant brain tumors including glioblastoma multiforme (GBM). DCVax-Brain composition and efficacy are not fully disclosed, although sponsors claim it is poised to critically test clinical DC vaccine efficacy in GBM patients.
Challenges in the development of a survivin vaccine (SurVaxM) for malignant glioma. [2022]There is growing interest in immunotherapy for malignant gliomas. This interest stems from a number of immunological observations, together with the failure of conventional therapeutic agents to produce broad and clinically meaningful improvements in survival and quality of life. The challenges faced in translating laboratory-based immunological observations to Phase I and II clinical trials for immunotherapy of gliomas are substantial. Nevertheless, as our understanding of the effects of active specific vaccination in glioma patients grows, results support optimism that such methods may eventually prove useful as an adjunctive treatment for these cancers. This paper highlights a number of barriers encountered in the translational development of a survivin-targeted peptide vaccine (SurVaxM) for patients with malignant gliomas.
Dendritic cell immunotherapy for solid tumors: evaluation of the DCVax® platform in the treatment of glioblastoma multiforme. [2019]DCVax(®) (Northwest Biotherapeutics, Inc., MD, USA) is a platform technology for delivering dendritic cell based therapeutic vaccines for a variety of cancers, including glioblastoma multiforme (GBM). DCVax(®)-L, one of the implementations of the DCVax platform, provides personalized active immunotherapy composed of autologous dendritic cells pulsed with autologous whole tumor lysate. Clinical trials with DCVax-L for GBM included previous Phase I/II clinical trials and an ongoing Phase III trial. Preliminary reports of patient outcomes after administration of the DCVax-L vaccine provide a promising therapeutic paradigm for patients with both initially diagnosed and recurrent GBM. Here we evaluate the current literature and clinical experience with the DCVax platform, with a particular focus on GBM treatment.
Vaccination strategies for neuro-oncology. [2018]Vaccination against cancer-associated antigens has long held the promise of inducting potent antitumor immunity, targeted cytotoxicity while sparing normal tissues, and long-lasting immunologic memory that can provide surveillance against tumor recurrence. Evaluation of vaccination strategies in preclinical brain tumor models has borne out the capacity for the immune system to effectively and safely eradicate established tumors within the central nervous system. Early phase clinical trials have established the feasibility, safety, and immunogenicity of several vaccine platforms, predominantly in patients with glioblastoma. Definitive demonstration of clinical benefit awaits further study, but initial results have been encouraging. With increased understanding of the stimulatory and regulatory pathways that govern immunologic responses and the enhanced capacity to identify novel antigenic targets using genomic interrogation of tumor cells, vaccination platforms for patients with malignant brain tumors are advancing with increasing personalized complexity and integration into combinatorial treatment paradigms.
Clinical study of a survivin long peptide vaccine (SurVaxM) in patients with recurrent malignant glioma. [2023]Survivin is an anti-apoptotic protein that is highly expressed in many cancers, including malignant gliomas. Preclinical studies established that the conjugated survivin peptide mimic SurVaxM (SVN53-67/M57-KLH) could stimulate an anti-tumor immune response against murine glioma in vivo, as well as human glioma cells ex vivo. The current clinical study was conducted to test safety, immunogenicity and clinical effects of the vaccine. Recurrent malignant glioma patients whose tumors were survivin-positive, and who had either HLA-A*02 or HLA-A*03 MHC class I allele-positivity, were given subcutaneous injections of SurVaxM (500 μg) in Montanide ISA 51 with sargramostim (100 μg) at 2-week intervals. SurVaxM was well tolerated with mostly grade one adverse events (AE) and no serious adverse events (SAE) attributable to the study drug. Six patients experienced local injection site reactions; three patients reported fatigue (grades 1 and 2), and 2 patients experienced myalgia (grade 1). Six of eight immunologically evaluable patients developed both cellular and humoral immune responses to vaccine. The vaccine also stimulated HLA-A*02, HLA-A*03 and HLA-A*24 restricted T cell responses. Three patients maintained a partial clinical response or stable disease for more than 6 months. Median progression-free survival was 17.6 weeks, and median overall survival was 86.6 weeks from study entry with seven of nine patients surviving more than 12 months.
Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma. [2023]Despite intensive treatment with surgery, radiation therapy, temozolomide (TMZ) chemotherapy, and tumor-treating fields, mortality of newly diagnosed glioblastoma (nGBM) remains very high. SurVaxM is a peptide vaccine conjugate that has been shown to activate the immune system against its target molecule survivin, which is highly expressed by glioblastoma cells. We conducted a phase IIa, open-label, multicenter trial evaluating the safety, immunologic effects, and survival of patients with nGBM receiving SurVaxM plus adjuvant TMZ following surgery and chemoradiation (ClinicalTrials.gov identifier: NCT02455557).
Autologous tumor lysate-loaded dendritic cell vaccination in glioblastoma: What happened to the evidence? [2023]In patients with glioblastoma, the "DCVax-L" trial reported a survival benefit with the addition of autologous tumor lysate-loaded denditric cell vaccination to the standard-of-care (SoC) in patients with glioblastoma. The trial presented as a phase 3 externally controlled trial is showing an improvement in overall survival (OS) in patients receiving the vaccine therapy as compared to externally controlled patients, both in the newly diagnosed setting (median OS = 19.3 months versus 16.5 months; HR = 0.80; 98% CI, 0.00-0.94; P = 0.002) and in the recurrent setting (median OS = 13.2 months versus 7.8 months; HR = 0.58; 98% CI, 0.00-0.76; P