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Completed

NCT Number: NCT00458601

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

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Key information

Conditions

Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Celldex Investigational Site, Orange, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CDX-110 with GM-CSF

Drug

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®)

Temozolomide

Drug

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

Primary outcomes

  1. Progression-free survival status

    Time frame: 5.5mo

Secondary outcomes

  1. Safety and tolerability characterized by adverse events (term, grade, frequency).

    Time frame: 2 years

  2. Safety and tolerability characterized by physical examinations.

    Time frame: 2 years

  3. Safety and tolerability characterized by hematologic and metabolic panel (including CBC with differential, electrolytes, BUN, Cr, liver associated enzymes).

    Time frame: 2 years

  4. Safety and tolerability characterized by urinalysis.

    Time frame: 2 years

  5. Safety and tolerability characterized by vital signs.

    Time frame: 2 years

  6. Immune response; T-cell response to vaccine.

    Time frame: 2 years

  7. Immune response; antibody response to vaccine.

    Time frame: 2 years

  8. Immune response; HLA typing.

    Time frame: 2 years

  9. Overall survival.

    Time frame: indeterminate

Sponsors and collaborators

Lead sponsor

Celldex Therapeutics

Industry

Registry information

Official study title

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

Acronym: ACT III

Important dates

Study start
2007
Primary completion
2010
Study completion
2016
First posted
Apr 11, 2007
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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