Recurrent Glioblastoma Clinical Trial
Official title:
Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Recurrent Glioblastoma
Verified date | June 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot early phase I trial studies the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2, 2021 |
Est. primary completion date | June 2, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - First or second recurrence of previously histologically confirmed glioblastoma (grade 4 astrocytoma) - NOTE: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) may be included, primitive neuroectodermal tumor (PNET) variants are excluded; grade 4 oligodendrogliomas or oligoastrocytomas are specifically excluded - Prior craniotomy and gross total or sub-total resection of tumor at this recurrence NOTE: biopsy of this recurrence alone without attempt at resection does not meet this inclusion criteria (i.e. craniotomy and resection is still required). - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 - Absolute neutrophil count (ANC) >= 1500/uL - Monocytes >= 300/uL - Platelets (PLT) >= 100,000/uL - Hemoglobin (HgB) >= 9.0 g/dL - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x ULN - Creatinine =< 1.5 x ULN - Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only - Ability to understand and willingness to sign written informed consent - Willing to return to Mayo Clinic in Rochester, Minnesota for follow-up - Willing to provide tissue and blood samples for mandatory correlative research purposes - Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 7 days prior to registration Exclusion Criteria: - Prior treatment - Current or prior treatment for this cancer with immunotherapy and/or any other investigational agents - Surgery =< 2 weeks prior to registration - Radiotherapy =< 12 weeks prior to registration - Treatment with bevacizumab or any cytotoxic chemotherapy =< 8 weeks prior to registration - Any of the following - Pregnant persons - Nursing persons - Persons of childbearing potential who are unwilling to employ adequate contraception - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B (HepB), or hepatitis C (HepC) positive - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - History of other malignancy other than glioma - EXCEPTIONS: non-melanotic skin cancer, carcinoma-in-situ of the cervix, or systemic cancer that has been in documented remission for > 10 years - NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer - History of myocardial infarction =< 180 days (6 months), or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias - Active infection =< 5 days prior to registration or fever >/= 38 degrees Celsius (C) within 5 days prior to registration - History of tuberculosis or positive purified protein derivative (PPD) test - Inability or unwillingness to have magnetic resonance imaging (MRI) scans performed (e.g. cardiac pacemaker-dependent) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in immunologic correlates | Change in immunologic correlates before and after vaccination treatment will be evaluated and summarized both quantitatively and graphically. Will use Spearman rank correlation coefficient to assess the correlations between baseline levels as well as between changes before and after treatment in these immunologic markers. In addition, these immunologic markers will be correlated with cancer and treatment-related outcomes (e.g. response, toxicities). Relationships will also be explored graphically using scatter plots. | Baseline up to 5 years | |
Primary | Incidence of significant toxicity, defined as a dose limiting toxicity (DLT) that is possibly, probably, or definitely related to treatment as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Incidence of significant toxicity will be estimated by the number of patients with significant toxicity divided by the total number of evaluable patients. | Up to 5 years | |
Secondary | Clinical benefit rate | The clinical benefit rate will be estimated by the number of patients with an overall survival for at least 6 months after enrollment or an objective status of CR or PR at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true clinical benefit rate will be calculated. | Up to 5 years | |
Secondary | Duration of response | Duration of response will be summarized descriptively. | Date at which the patient?s objective status is first noted to be either a CR or PR to the earliest date progression is documented, assessed up to 5 years | |
Secondary | Feasibility | The feasibility of the regimen will be estimated by the number of patients who received at least one dose of dendritic cell (DC) injection divided by the total number of patients who received leukapheresis in that arm. | Up to 5 years | |
Secondary | Overall response rate | The overall response rate will be estimated by the number of patients with an objective status of complete response (CR) or partial response (PR) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. | Up to 5 years | |
Secondary | Overall survival | Time from study registration to progression and death due to any cause, assessed up to 5 years | ||
Secondary | Progression-free survival | Time from study registration to progression and death due to any cause, assessed up to 5 years | ||
Secondary | Time to response | Time to response will be summarized descriptively. | Date of initiation of vaccination treatment to the date at which the patient?s objective status is first noted to be either a CR or PR, assessed up to 5 years |
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