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Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

Primary Purpose

Astrocytoma, Brainstem Glioma, Ependymoma

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Radiation therapy
Temozolomide
Stem cell collection
Stem cell infusion
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astrocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV).
  • At least 18 years of age.
  • Karnofsky performance status ≥ 60%
  • Normal bone marrow and organ function as defined below:

    • Absolute neutrophil count ≥ 1,500/mcl
    • Platelets ≥ 100,000/mcl
    • Hematocrit ≥ 30%
    • Absolute lymphocyte count ≥ 1000/mcl Blood transfusions are permitted to allow potential participant to meet these criteria.
  • Post-operative treatment plan must include standard radiation and temozolomide.
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  • Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy. Glucocorticoid therapy is allowed.
  • Anti-VEGF therapy within 6 weeks of registration.
  • A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
  • Currently receiving any investigational agents that might affect lymphocytes. Patients receiving Novocure are allowed on study.
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study.
  • Fresh CNS bleed as evident by MRI or CT.
  • Contraindicated for anticoagulation.
  • 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.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Known HIV-positivity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Focal RT, Temozolomide, Stem Cell Collection/Reinfusion

    Arm Description

    Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide Focal radiation therapy: standard of care dose daily for approximately 6 weeks Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide

    Outcomes

    Primary Outcome Measures

    Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
    The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.

    Secondary Outcome Measures

    Number of lymphocyte stem cells that can be harvested from this patient population
    Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
    Duration of lymphocyte rise following stem cell reinfusion
    Changes in lymphocyte subtypes following collection and reinfusion
    Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.
    Changes in series of cytokine levels following collection and reinfusion
    Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.
    Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
    the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.

    Full Information

    First Posted
    November 23, 2016
    Last Updated
    February 16, 2017
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02976441
    Brief Title
    Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
    Official Title
    Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Physician decided not to go through with study
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    February 2018 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators hypothesize that this study will show that sufficient lymphocyte stem cell can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5 of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300 cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Astrocytoma, Brainstem Glioma, Ependymoma, Mixed Glioma, Oligodendroglioma, Optic Nerve Glioma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
    Arm Type
    Experimental
    Arm Description
    Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide Focal radiation therapy: standard of care dose daily for approximately 6 weeks Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation 2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiation therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Temozolomide
    Other Intervention Name(s)
    Temodar®
    Intervention Type
    Procedure
    Intervention Name(s)
    Stem cell collection
    Intervention Type
    Procedure
    Intervention Name(s)
    Stem cell infusion
    Primary Outcome Measure Information:
    Title
    Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
    Description
    The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.
    Time Frame
    Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
    Secondary Outcome Measure Information:
    Title
    Number of lymphocyte stem cells that can be harvested from this patient population
    Time Frame
    Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
    Title
    Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
    Time Frame
    4 weeks after stem cell reinfusion
    Title
    Duration of lymphocyte rise following stem cell reinfusion
    Time Frame
    Up to 6 months after stem cell reinfusion (approximately 9 months)
    Title
    Changes in lymphocyte subtypes following collection and reinfusion
    Description
    Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.
    Time Frame
    Up to 6 months after stem cell reinfusion (approximately 9 months)
    Title
    Changes in series of cytokine levels following collection and reinfusion
    Description
    Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.
    Time Frame
    Up to 6 months after stem cell reinfusion (approximately 9 months)
    Title
    Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
    Description
    the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.
    Time Frame
    Up to 6 months after stem cell reinfusion (approximately 9 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III or IV). At least 18 years of age. Karnofsky performance status ≥ 60% Normal bone marrow and organ function as defined below: Absolute neutrophil count ≥ 1,500/mcl Platelets ≥ 100,000/mcl Hematocrit ≥ 30% Absolute lymphocyte count ≥ 1000/mcl Blood transfusions are permitted to allow potential participant to meet these criteria. Post-operative treatment plan must include standard radiation and temozolomide. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy. Glucocorticoid therapy is allowed. Anti-VEGF therapy within 6 weeks of registration. A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. Currently receiving any investigational agents that might affect lymphocytes. Patients receiving Novocure are allowed on study. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to filgrastim or plerixafor or other agents used in the study. Fresh CNS bleed as evident by MRI or CT. Contraindicated for anticoagulation. 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. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. Known HIV-positivity.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jian Li Campian, M.D., Ph.D.
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.siteman.wustl.edu
    Description
    Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

    Learn more about this trial

    Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas

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