- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00458601
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
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California
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Orange, California, United States, 92868
- Celldex Investigational Site
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San Francisco, California, United States, 94143-0622
- Celldex Investigational Site
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San Francisco, California, United States, 94143
- Celldex Investigational Site
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Stanford, California, United States, 94305-5826
- Celldex Investigational Site
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Stanford, California, United States, 94305
- Celldex Investigational Site
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Connecticut
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New Haven, Connecticut, United States, 06510
- Celldex Investigational Site
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New Haven, Connecticut, United States, 06519
- Celldex Investigational Site
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New Haven, Connecticut, United States, 06520
- Celldex Investigational Site
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Florida
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Gainesville, Florida, United States, 32610-0277
- Celldex Investigational Site
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Illinois
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Chicago, Illinois, United States, 60611
- Celldex Investigational Site
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Evanston, Illinois, United States, 60201
- Celldex Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Celldex Investigational Site
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Michigan
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Lansing, Michigan, United States, 48912
- Celldex Investigational Site
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Saginaw, Michigan, United States, 48601
- Celldex Investigational Site
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Saginaw, Michigan, United States, 48604
- Celldex Investigational Site
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Celldex Investigational Site
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New York
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Amherst, New York, United States, 14226
- Celldex Investigational Site
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New York, New York, United States, 10032
- Celldex Investigational Site
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New York, New York, United States, 10065
- Celldex Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27710
- Celldex Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45219
- Celldex Investigational Site
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Cincinnati, Ohio, United States, 45267-0502
- Celldex Investigational Site
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Cincinnati, Ohio, United States, 45267-0769
- Celldex Investigational Site
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Cleveland, Ohio, United States, 44106
- Celldex Investigational Site
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Cleveland, Ohio, United States, 44195
- Celldex Investigational Site
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Orange Village, Ohio, United States, 44122
- Celldex Investigational Site
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West Chester, Ohio, United States, 45069-6542
- Celldex Investigational Site
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Westlake, Ohio, United States, 44145
- Celldex Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Celldex Investigational Site
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Texas
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Houston, Texas, United States, 77030
- Celldex Investigational Site
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San Antonio, Texas, United States, 78229
- Celldex Investigational Site
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Utah
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Salt Lake City, Utah, United States, 84112
- Celldex Investigational Site
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Virginia
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Charlottesville, Virginia, United States, 22908
- Celldex Investigational Site
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Washington
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Seattle, Washington, United States, 98195
- Celldex Investigational Site
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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 |
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Experimental: CDX-110 with GM-CSF
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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:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival status
Time Frame: 5.5mo
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5.5mo
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Safety and tolerability characterized by adverse events (term, grade, frequency).
Time Frame: 2 years
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2 years
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Safety and tolerability characterized by physical examinations.
Time Frame: 2 years
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2 years
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Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
Time Frame: 2 years
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2 years
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Safety and tolerability characterized by urinalysis.
Time Frame: 2 years
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2 years
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Safety and tolerability characterized by vital signs.
Time Frame: 2 years
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2 years
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Immune response; T-cell response to vaccine.
Time Frame: 2 years
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2 years
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Immune response; antibody response to vaccine.
Time Frame: 2 years
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2 years
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Immune response; HLA typing.
Time Frame: 2 years
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2 years
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Overall survival.
Time Frame: indeterminate
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indeterminate
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Glioma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Immunological
- Temozolomide
- Sargramostim
- Rindopepimut
- Molgramostim
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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