Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma (NCT01635283) | Clinical Trial Compass
CompletedPhase 2
Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
United States5 participantsStarted 2012-01-10
Plain-language summary
The primary purpose of this phase II clinical trial is to determine the safety and effect on survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a treatment for low-grade glioma patients. Other goals of this study are to determine if the vaccine can cause an immune response against patients' cancer cells and slow the growth of their brain tumors
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO) grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible for this protocol
* Patients must have had surgical resection at University of California, Los Angeles (UCLA), for which a separate informed consent was signed for the collection of their tumor prior to surgery
* After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need to be established
* Patients must be able to read and understand the informed consent document; patients must sign the informed consent indicating that they are aware of the investigational nature of this study.
* Patients must have a Karnofsky performance status (KPS) rating of \>= 60 prior to initiating treatment; patients may be enrolled at a KPS of \< 60 if it is felt that the patient will have adequate opportunity to recover to a KPS of \>= 60 by the initiation of treatment
* Hemoglobin \>= 9 gm%
* Absolute granulocyte count \>= 1,500
* Platelet count \>= 100,000/microliter (uL)
* Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times institutional normals
* Bilirubin =\< 1.5mg%
* Blood urea nitrogen (BUN) or creatinine =\< 1.5 times institutional normals
Exclusion Criteria:
* Subjects with an active infection
* Inability to obtain informed consent because of psychiatric or complicating medical problems
* Unstable or severe intercurrent m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate
Timeframe: Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months.