Phase II Study of CDX-110 in Patients With Glioblastoma Multiforme - Full Text View

Sponsor:	Celldex Therapeutics
Information provided by:	Celldex Therapeutics
ClinicalTrials.gov Identifier:	NCT00458601

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 II

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:

MedlinePlus related topics: Cancer

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Temozolomide Sargramostim

U.S. FDA Resources

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 2011
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

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

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:	Thomas Davis, MD, 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:	November 15, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celldex Therapeutics:

EGFRvIII vaccine temozolomide cancer vaccine immunotherapy

Additional relevant MeSH terms:

Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 02, 2012