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Derivation of Tumor Specific Hybridomas

Primary Purpose

Glioblastoma

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tumor Vaccine
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Immunotherapy, cancer vaccine, glioblastoma, hybridoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery
  • Age > 18 years
  • KPS Score of greater than or equal to 70
  • Adequate bone marrow as evidenced by:

Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL

  • Adequate renal function as evidenced by serum creatinine < 2.0
  • Patients must be able to read, understand and provide informed consent to participate in the trial.
  • Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

A patient may not be enrolled in the trial if any of the following criteria are met:

  • Patients receiving dexamethasone > 8 mg/day during the week before vaccination.
  • Patients who are pregnant or lactating
  • Patients with active second malignancy.
  • Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Tumor Vaccine

    Arm Description

    1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.

    Outcomes

    Primary Outcome Measures

    number of hybridoma clones that produce anti-glioma antibodies
    The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.

    Secondary Outcome Measures

    Production of Antibodies
    Secondary outcomes will include: Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies.
    Toxicity of Vaccine
    • Determining toxicity of vaccine
    Clone Production Rate
    Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node.
    Lymph Node Biopsy
    Determine the safety and toxicity issues related to the Lymph Node Biopsy

    Full Information

    First Posted
    October 3, 2012
    Last Updated
    April 2, 2018
    Sponsor
    Dartmouth-Hitchcock Medical Center
    Collaborators
    University of Vermont
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01702792
    Brief Title
    Derivation of Tumor Specific Hybridomas
    Official Title
    Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Investigator is leaving Dartmouth
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    May 6, 2015 (Actual)
    Study Completion Date
    May 6, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dartmouth-Hitchcock Medical Center
    Collaborators
    University of Vermont

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.
    Detailed Description
    The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done twice and separated by one week. The first vaccination will be performed approximately 2 weeks after surgery. Approximately one week after the second vaccination one or two vaccine-draining lymph node(s) will be removed. The lymph node(s) will be identified using SN technology. One or two lymph node(s) will be removed. Lymph nodes will be processed for recovery of B cells and formation of hybridomas.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma
    Keywords
    Immunotherapy, cancer vaccine, glioblastoma, hybridoma

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Tumor Vaccine
    Arm Type
    Experimental
    Arm Description
    1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.
    Intervention Type
    Biological
    Intervention Name(s)
    Tumor Vaccine
    Other Intervention Name(s)
    Autologous Tumor Lysate and Montanide Emulsion
    Intervention Description
    Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.
    Primary Outcome Measure Information:
    Title
    number of hybridoma clones that produce anti-glioma antibodies
    Description
    The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Production of Antibodies
    Description
    Secondary outcomes will include: Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies.
    Time Frame
    6 months
    Title
    Toxicity of Vaccine
    Description
    • Determining toxicity of vaccine
    Time Frame
    6 months
    Title
    Clone Production Rate
    Description
    Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node.
    Time Frame
    6 months
    Title
    Lymph Node Biopsy
    Description
    Determine the safety and toxicity issues related to the Lymph Node Biopsy
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Tumor Binding Characteristics
    Description
    Exploratory objectives will include: Determining the rate of tumor binding antibodies from hybridomas derived from circulating B cells. Determining the tumor-binding profile of antibodies present in the blood.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least 8x10(7) tumor cells obtained at the time of surgery Age > 18 years KPS Score of greater than or equal to 70 Adequate bone marrow as evidenced by: Absolute lymphocyte count > 1,000/uL Platelet count > 50,000/uL Adequate renal function as evidenced by serum creatinine < 2.0 Patients must be able to read, understand and provide informed consent to participate in the trial. Patients of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following vaccination (an effective form of contraception is an oral contraceptive or a double barrier method) Exclusion Criteria: A patient may not be enrolled in the trial if any of the following criteria are met: Patients receiving dexamethasone > 8 mg/day during the week before vaccination. Patients who are pregnant or lactating Patients with active second malignancy. Any other medical conditions, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Camilo Fadul, MD
    Organizational Affiliation
    Dartmouth-Hitchcock Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Derivation of Tumor Specific Hybridomas

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