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

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Locations

United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94143
Pfizer Investigational Site
San Francisco, California, United States, 94143-0622
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Stanford, California, United States, 94305
Pfizer Investigational Site
Stanford, California, United States, 94305-5826
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
Orange, California, United States, 92868
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32224
Pfizer Investigational Site
Gainesville, Florida, United States, 32610-0277
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Pfizer Investigational Site
Evanston, Illinois, United States, 60201
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Iowa
Pfizer Investigational Site
Iowa City, Iowa, United States, 52242
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287-4605
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Saginaw, Michigan, United States, 48601
Pfizer Investigational Site
Saginaw, Michigan, United States, 48604
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
Pfizer Investigational Site
Lansing, Michigan, United States, 48912
United States, New Jersey
Pfizer Investigational Site
Hackensack, New Jersey, United States, 07601
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
Syracuse, New York, United States, 13210
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
Amherst, New York, United States, 14226
Pfizer Investigational Site
New York, New York, United States, 10065
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Orange Village, Ohio, United States, 44122
Pfizer Investigational Site
Westlake, Ohio, United States, 44145
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0769
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267-0502
Pfizer Investigational Site
West Chester, Ohio, United States, 45069-6542
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84112
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22908
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98195

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:	November 20, 2009
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 November 27, 2009