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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics
ClinicalTrials.gov Identifier:
NCT00458601
First received: April 10, 2007
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Malignant Glioma
Drug: CDX-110 with GM-CSF
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Celldex Therapeutics:

Primary Outcome Measures:
  • Progression-free survival status [ Time Frame: 5.5mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability characterized by adverse events (term, grade, frequency). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by physical examinations. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes). [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by urinalysis. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Safety and tolerability characterized by vital signs. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Immune response; T-cell response to vaccine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immune response; antibody response to vaccine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Immune response; HLA typing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CDX-110
Maintenance temozolomide plus intradermal injections of 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 Name: 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 Name: Temodar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458601

  Show 34 Study Locations
Sponsors and Collaborators
Celldex Therapeutics
Investigators
Study Director: Thomas Davis, MD Celldex Therapeutics
  More Information

No publications provided

Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT00458601     History of Changes
Other Study ID Numbers: CDX110-003, CDX110-003
Study First Received: April 10, 2007
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Celldex Therapeutics:
EGFRvIII vaccine temozolomide cancer vaccine immunotherapy

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Dacarbazine
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014