Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme (ACT III)

January 11, 2018 updated by: Celldex Therapeutics

A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

This study is designed to evaluate the clinical activity of CDX-110 vaccination when given with standard of care treatment (maintenance temozolomide therapy). Study treatment will be given until disease progression and patients will be followed for long-term survival information. Efficacy will be measured by the progression-free survival status at 5.5 months from the date of first dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Celldex Investigational Site
      • San Francisco, California, United States, 94143-0622
        • Celldex Investigational Site
      • San Francisco, California, United States, 94143
        • Celldex Investigational Site
      • Stanford, California, United States, 94305-5826
        • Celldex Investigational Site
      • Stanford, California, United States, 94305
        • Celldex Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Celldex Investigational Site
      • New Haven, Connecticut, United States, 06519
        • Celldex Investigational Site
      • New Haven, Connecticut, United States, 06520
        • Celldex Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610-0277
        • Celldex Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Celldex Investigational Site
      • Evanston, Illinois, United States, 60201
        • Celldex Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Celldex Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Celldex Investigational Site
      • Saginaw, Michigan, United States, 48601
        • Celldex Investigational Site
      • Saginaw, Michigan, United States, 48604
        • Celldex Investigational Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Celldex Investigational Site
    • New York
      • Amherst, New York, United States, 14226
        • Celldex Investigational Site
      • New York, New York, United States, 10032
        • Celldex Investigational Site
      • New York, New York, United States, 10065
        • Celldex Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Celldex Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Celldex Investigational Site
      • Cincinnati, Ohio, United States, 45267-0502
        • Celldex Investigational Site
      • Cincinnati, Ohio, United States, 45267-0769
        • Celldex Investigational Site
      • Cleveland, Ohio, United States, 44106
        • Celldex Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Celldex Investigational Site
      • Orange Village, Ohio, United States, 44122
        • Celldex Investigational Site
      • West Chester, Ohio, United States, 45069-6542
        • Celldex Investigational Site
      • Westlake, Ohio, United States, 44145
        • Celldex Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Celldex Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Celldex Investigational Site
      • San Antonio, Texas, United States, 78229
        • Celldex Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Celldex Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Celldex Investigational Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Celldex Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue.
  • Gross total resection followed by conventional chemoradiation therapy without progression of disease.

Exclusion Criteria:

  • Presence of diffuse leptomeningeal disease or gliomatosis cerebri.
  • Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent (as defined by the investigator) per day at study enrollment.
  • Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel® Wafers.
  • Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDX-110 with GM-CSF
Drug: CDX-110 with GM-CSF
Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.
Other Names:
  • CDX-110 with sargramostim (GM-CSF) (Leukine®)
Drug: Temozolomide
Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.
Other Names:
  • Temodar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival status
Time Frame: 5.5mo
5.5mo

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability characterized by adverse events (term, grade, frequency).
Time Frame: 2 years
2 years
Safety and tolerability characterized by physical examinations.
Time Frame: 2 years
2 years
Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
Time Frame: 2 years
2 years
Safety and tolerability characterized by urinalysis.
Time Frame: 2 years
2 years
Safety and tolerability characterized by vital signs.
Time Frame: 2 years
2 years
Immune response; T-cell response to vaccine.
Time Frame: 2 years
2 years
Immune response; antibody response to vaccine.
Time Frame: 2 years
2 years
Immune response; HLA typing.
Time Frame: 2 years
2 years
Overall survival.
Time Frame: indeterminate
indeterminate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celldex Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 10, 2007

First Submitted That Met QC Criteria

April 10, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX110-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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