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 range18 Years
SexALL
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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…
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.