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Cancer Vaccine
Vaccine Therapy + Temozolomide for Glioblastoma
Phase 2
Waitlist Available
Led By Robert Fenstermaker
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years
Awards & highlights
Study Summary
This trial is testing a vaccine therapy given with temozolomide to see if it is effective in treating patients with newly diagnosed glioblastoma.
Who is the study for?
This trial is for patients with newly diagnosed glioblastoma who've had surgery and chemotherapy with temozolomide, without disease progression. They must have a specific immune system type (HLA-A*02, A*03, A*11 or A*24), good kidney function, no serious bleeding risks or infections, not be pregnant or breastfeeding, and agree to use contraception.Check my eligibility
What is being tested?
The study tests if adding a survivin peptide vaccine (SurVaxM) to the standard treatment of temozolomide improves outcomes in glioblastoma patients. The vaccine aims to help the body's immune system attack tumor cells that express survivin—a protein found in cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine therapy, flu-like symptoms such as fever and chills, fatigue from temozolomide chemotherapy, and potential blood-related issues like low platelet counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of diagnosis until (1) date of death or (2) the last date patient known alive (if death is not observed), assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Immune Responses to SurVaxM and Predictors of Response
Incidence of Grade 3 or 4 Toxicities, According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SurVaxM, temozolomide)Experimental Treatment5 Interventions
Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Montanide ISA 51 VG
2008
Completed Phase 3
~610
Sargramostim
2008
Completed Phase 4
~710
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,792 Total Patients Enrolled
5 Trials studying Glioblastoma
92 Patients Enrolled for Glioblastoma
Robert FenstermakerPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Glioblastoma
9 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer in the last 3 years, except for treated skin cancer or carcinoma-in-situ.I am currently on cancer treatment other than temozolomide.I've had brain surgery after radiation and chemotherapy for my tumor.I have received additional treatments besides radiation and temozolomide.I have not received immunotherapy for my brain tumor.I have not used Gliadel wafers or electrical field therapy for my condition.You have a previous diagnosis of an autoimmune disease.I have HIV/AIDS or another serious illness.My MRI after surgery shows no large remaining cancer areas.My tumor tests positive for survivin.I can take care of myself but might need help sometimes.I have been diagnosed with a severe form of brain cancer.I am on full-dose anticoagulants like warfarin or LMW heparin.I do not have any conditions that cause frequent bleeding.My cancer has not worsened after treatment, based on exams and scans.I finished my initial treatment for glioblastoma, including radiation and most of the chemotherapy.I have a positive HLA-A*02, HLA-A*03, HLA-A*11, or HLA-A*24 status.I am taking 4 mg or less of dexamethasone daily.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SurVaxM, temozolomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main health concerns that SVN53-67/M57-KLH Peptide Vaccine has been shown to help with?
"SVN53-67/M57-KLH Peptide Vaccine is used to target glioblastoma multiforme (gbm), as well as acute lymphoblastic leukemia (all), melanoma, and soft tissue sarcoma (sts)."
Answered by AI
Are we still able to enroll people in this experiment?
"This particular trial is not actively recruiting patients at this time. However, there are 459 other clinical trials for glioblastoma and 257 studies for SVN53-67/M57-KLH Peptide Vaccine that are currently looking for participants."
Answered by AI
Are there any precedents for this SVN53-67/M57-KLH Peptide Vaccine?
"The SVN53-67/M57-KLH Peptide Vaccine was first researched over two decades ago. With one thousand completed trials and 257 studies still underway, this intervention has been widely studied. A large portion of the current research is being conducted in Boston, MA."
Answered by AI
What is the government regulatory agency's stance on SVN53-67/M57-KLH Peptide Vaccine?
"The safety of SVN53-67/M57-KLH Peptide Vaccine is rated as a 2. This is due to it being a Phase 2 trial, so while there is some data supporting its safety, there is none yet for efficacy."
Answered by AI
What is the projected enrollment for this clinical trial?
"Presently, this particular trial is not looking for more patients. It was posted on May 4th, 2015 and last updated March 21st, 2022. However, if you're still interested in participating in clinical trials, there are currently 459 studies actively recruiting patients with glioblastoma and 257 studies for the SVN53-67/M57-KLH Peptide Vaccine with open enrollment."
Answered by AI
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