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

Primary Purpose

Malignant Glioma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CDX-110 with GM-CSF
Temozolomide
Sponsored by
Celldex Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma focused on measuring EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy

Eligibility Criteria

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

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.

Sites / Locations

  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site
  • Celldex Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CDX-110 with GM-CSF

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival status

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2007
Last Updated
January 11, 2018
Sponsor
Celldex Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00458601
Brief Title
Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme
Acronym
ACT III
Official Title
A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma
Keywords
EGFRvIII vaccinetemozolomidecancer vaccineimmunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDX-110 with GM-CSF
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CDX-110 with GM-CSF
Other Intervention Name(s)
CDX-110 with sargramostim (GM-CSF) (Leukine®)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival status
Time Frame
5.5mo
Secondary Outcome Measure Information:
Title
Safety and tolerability characterized by adverse events (term, grade, frequency).
Time Frame
2 years
Title
Safety and tolerability characterized by physical examinations.
Time Frame
2 years
Title
Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).
Time Frame
2 years
Title
Safety and tolerability characterized by urinalysis.
Time Frame
2 years
Title
Safety and tolerability characterized by vital signs.
Time Frame
2 years
Title
Immune response; T-cell response to vaccine.
Time Frame
2 years
Title
Immune response; antibody response to vaccine.
Time Frame
2 years
Title
Immune response; HLA typing.
Time Frame
2 years
Title
Overall survival.
Time Frame
indeterminate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Celldex Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Celldex Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0622
Country
United States
Facility Name
Celldex Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Celldex Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5826
Country
United States
Facility Name
Celldex Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Celldex Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Celldex Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Celldex Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Celldex Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0277
Country
United States
Facility Name
Celldex Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Celldex Investigational Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Celldex Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Celldex Investigational Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Celldex Investigational Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Celldex Investigational Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Celldex Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Celldex Investigational Site
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Celldex Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Celldex Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Celldex Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Celldex Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Celldex Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States
Facility Name
Celldex Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0769
Country
United States
Facility Name
Celldex Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Celldex Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Celldex Investigational Site
City
Orange Village
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Celldex Investigational Site
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069-6542
Country
United States
Facility Name
Celldex Investigational Site
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Celldex Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Celldex Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Celldex Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Celldex Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Celldex Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Celldex Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25586468
Citation
Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, Mrugala MM, Jensen R, Baehring JM, Sloan A, Archer GE, Bigner DD, Cruickshank S, Green JA, Keler T, Davis TA, Heimberger AB, Sampson JH. A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. Neuro Oncol. 2015 Jun;17(6):854-61. doi: 10.1093/neuonc/nou348. Epub 2015 Jan 13.
Results Reference
result

Learn more about this trial

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

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