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Derivation of Tumor Specific Hybridomas

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. Read our disclaimer for details. Identifier: NCT01702792
Recruitment Status : Terminated (Investigator is leaving Dartmouth)
First Posted : October 8, 2012
Last Update Posted : April 4, 2018
University of Vermont
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE October 3, 2012
First Posted Date  ICMJE October 8, 2012
Last Update Posted Date April 4, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date May 6, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2012)
number of hybridoma clones that produce anti-glioma antibodies [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2012)
  • Production of Antibodies [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    • Determining toxicity of vaccine
  • Clone Production Rate [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Determine the safety and toxicity issues related to the Lymph Node Biopsy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 5, 2012)
Tumor Binding Characteristics [ Time Frame: 6 months ]
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.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Derivation of Tumor Specific Hybridomas
Official Title  ICMJE Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Biological: Tumor Vaccine
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.
Other Name: Autologous Tumor Lysate and Montanide Emulsion
Study Arms  ICMJE Experimental: Tumor Vaccine
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: Biological: Tumor Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 14, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2012)
Actual Study Completion Date  ICMJE May 6, 2015
Actual Primary Completion Date May 6, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
Administrative Information
NCT Number  ICMJE NCT01702792
Other Study ID Numbers  ICMJE W12209
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE University of Vermont
Investigators  ICMJE
Principal Investigator: Camilo Fadul, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP