Phase II Study of PF-04948568 (CDX-110) in Patients With Glioblastoma Multiforme - Full Text View

Sponsor:	Pfizer
Collaborator:	Celldex Therapeutics
Information provided by:	Pfizer
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: PF-04948568 (CDX-110) with GM-CSF Drug: temozolomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of PF-04948568 (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 Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Establish the safety and tolerability profile(s) of the CDX-110 vaccination schedule in these patients. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Assess humoral and cellular immune responses to CDX-110 vaccinations and explore the overall immunogenicity of the vaccine as well as any interactions with steroid dosing and maintenance temozolomide. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Assess overall survival. [ Time Frame: indeterminate ] [ Designated as safety issue: No ]

Estimated Enrollment:	82
Study Start Date:	August 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CDX-110: Experimental Maintenance temozolomide plus intradermal injections of CDX-110 with GM-CSF.	Drug: PF-04948568 (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 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.

Arms

Assigned Interventions

CDX-110: Experimental

Maintenance temozolomide plus intradermal injections of CDX-110 with GM-CSF.

Drug: PF-04948568 (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

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.

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 44 Study Locations

Sponsors and Collaborators

Pfizer

Celldex Therapeutics

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1331001, CDX110-003
Study First Received:	April 10, 2007
Last Updated:	January 14, 2010
ClinicalTrials.gov Identifier:	NCT00458601 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

EGFRvIII vaccine temozolomide cancer vaccine immunotherapy

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Neoplasms, Nerve Tissue
Temozolomide
Pharmacologic Actions
Neuroectodermal Tumors

Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010