We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 1883 for:    "Mayo Clinic" [Exact]

Vaccine Therapy and Cytokine-Induced Killer Cells in Treating Patients With Recurrent Glioblastoma

This study is not yet open for participant recruitment.
Verified November 2017 by Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT03360708
First Posted: December 4, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  Purpose
This pilot early phase I trial studies the side effects of vaccine therapy and cytokine-induced killer cells 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. Cytokine-induced killer cells are white blood cells with a powerful ability to kill tumor cells without any further modification. Giving vaccine therapy and cytokine-induced killer cells may work better in treating patients with glioblastoma.

Condition Intervention Phase
Giant Cell Glioblastoma Recurrent Glioblastoma Recurrent Gliosarcoma Biological: Cytokine-Induced Killer Cells Other: Laboratory Biomarker Analysis Biological: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination and Autologous Cytokine-Induced Killer Cell Transfer in Recurrent Glioblastoma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 5 years ]
    Incidence of significant toxicity will be estimated by the number of patients with significant toxicity divided by the total number of evaluable patients.


Secondary Outcome Measures:
  • Clinical benefit rate [ Time Frame: Up to 5 years ]
    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.

  • Duration of response [ Time Frame: 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 ]
    Duration of response will be summarized descriptively.

  • Feasibility [ Time Frame: Up to 5 years ]
    The feasibility of the regimen will be estimated by the number of patients who received cytokine-induced killer cell (CIK) infusion or at least one dose of dendritic cell (DC) injection divided by the total number of patients who received leukapheresis in that arm.

  • Overall response rate [ Time Frame: Up to 5 years ]
    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.

  • Overall survival [ Time Frame: Time from study registration to progression and death due to any cause, assessed up to 5 years ]
  • Progression-free survival [ Time Frame: Time from study registration to progression and death due to any cause, assessed up to 5 years ]
  • Time to response [ Time Frame: 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 ]
    Time to response will be summarized descriptively.


Other Outcome Measures:
  • Change in immunologic correlates [ Time Frame: Baseline up to 5 years ]
    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.


Estimated Enrollment: 20
Anticipated Study Start Date: December 29, 2017
Estimated Study Completion Date: December 1, 2022
Estimated Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (cytokine-induced killer cells and vaccine therapy)
Patients receive cytokine-induced killer cells IV over 1 hour on day 13 of course 1. Patients also receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Biological: Cytokine-Induced Killer Cells
Given IV
Other Name: CIK
Other: Laboratory Biomarker Analysis
Correlative studies
Biological: Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine
Given ID

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the safety and feasibility of malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine (autologous dendritic cell [DC] / allogeneic glioblastoma multiforme [GBM] culture lysate vaccination) combined with autologous cytokine-activated killer cell transfer in glioblastoma patients at first or second recurrence.

SECONDARY OBJECTIVES:

I. To document survival and progression-free survival in glioblastoma patients at first or second recurrence receiving autologous DC / allogeneic GBM culture lysate vaccination combined with autologous cytokine-activated killer cell transfer and compare to historical data.

TERTIARY OBJECTIVES:

I. Determine the ability of autologous DC / GBM culture lysate vaccination combined with autologous cytokine-activated killer cell transfer to generate multiple tumor-associated antigen (TAA)-specific immune responses in GBM patients at first or second recurrence.

II. Assess the relationship between ability tumor induced TAA-specific immune responses and evidence of immunosuppression (peripheral blood immunophenotyping by flow cytometry) following autologous DC / allogeneic GBM culture lysate vaccination combined with autologous cytokine-activated killer cell transfer in GBM patients at first or second recurrence.

III. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and tumor-associated antigen immune response following autologous DC / allogeneic GBM culture lysate vaccination combined with autologous cytokine-activated killer cell transfer.

IV. Assess the relationship between efficacy endpoints (survival, progression-free survival, tumor response) and evidence of immunosuppression at baseline and over time with autologous DC / allogeneic GBM culture lysate vaccination combined with autologous cytokine-activated killer cell transfer.

OUTLINE:

Patients receive cytokine-induced killer cells intravenously (IV) over 1 hour on day 13 of course 1. Patients also receive malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 1, 3, and 5 of courses 2 and 3, and on day 1 of subsequent courses. Treatment with malignant glioma tumor lysate-pulsed autologous dendritic cell vaccine repeats every 21 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 5 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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) on day of 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360708


Locations
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Ian F. Parney         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ian Parney Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03360708     History of Changes
Other Study ID Numbers: MC1772
NCI-2017-02159 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1772 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Submitted: November 28, 2017
First Posted: December 4, 2017
Last Update Posted: December 7, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Glioblastoma
Gliosarcoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Immunologic Factors
Physiological Effects of Drugs