MDACC Study Summary 2007-0263

Study Summary
No. 2007-0263:.......Brain......Vinay K. Puduvalli......Neuro Oncology

Study Summary Title



Study Summary Number:	2007-0263

Study Title:	A Phase II Study of PF-04948568(CDX-110) with Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme

Physician

New Patient Referral



Name:	Vinay K. Puduvalli	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2883 Contact us about clinical trials

General Information



Disease Group:	Brain	Supported By:	Celldex Therapeutics

Phase of Study:	Phase II	Return Visit:	every two weeks for the first 4 weeks, and then every 4 weeks

Treatment Agents:	PEP-3-KLH Temozolomide	Home Care:	Temozolomide will be taken at home

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of the tumor tissue collection is to learn if you are eligible to enroll in the main research study. The purpose of the main research study is to learn if adding PF-04948568(CDX-110) to the commonly used chemotherapy drug temozolomide can help prevent brain tumors from growing. The safety of this combination will also be studied.

Study Objectives / Outcomes

The primary objective is to evaluate the clinical activity of CDX-110, defined by the progression-free survival status (PFS) at 5.5 months from Study Day 0.

Secondary objectives are to:

1) Establish the safety and tolerability profile(s) of the CDX-110 vaccination schedule(s) in these patients.

2) 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 temozolomide maintenance therapy (TMT).

3) Assess overall survival.

Study Status Information



Study Activation / Registration Date:	09/18/2007

IRB Review and Approval Date:	06/20/2007

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	60 Patients

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Newly diagnosed de novo GBM with documented EGFRvIII expression in tumor tissue (EGFRvIII expression assessed using a proprietary IHC assay performed at a central lab; a positive result will be one with >/= 10% cells positive)

2) Karnofsky Performance Status (KPS) of > 70%

3) Gross total resection followed by conventional chemoradiation therapy without evidence of progressive disease prior to enrollment (In order to be considered progressive disease, the sum of the products of the progressing lesions must exceed 1 cm2)

4) Patients may have 1 cm2 or less residual disease on post-operative contrast-enhanced magnetic resonance image (MRI) without disease progression prior to study entry. Patients with no residual enhancement are eligible. Any contiguous flare will be acceptable. However, a second site of disease will exclude the patient. There must be no evidence of progressive disease prior to enrollment based upon the definition in a modified Macdonald criteria.

5) Conventional chemoradiation should consist of radiotherapy at a minimally acceptable total dose of at least 90% of the planned dose (approximately 60 Gy) of absorbed radiation concurrent with a continuous daily temozolomide dose of at least 80% of the planned dose density (75 mg/m2 body surface area per day from the start to end of radiotherapy).

6) Men or women 18 years of age or older. Since it is not known whether CDX-110 is detrimental to unborn children or nursed infants, women must be surgically sterile or post-menopausal, or, if of child-bearing potential, must have a negative serum pregnancy test prior to study enrollment and must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study, while male patients with partners of childbearing potential must agree to practice hormonal or barrier birth control with spermicidal gel

7) Ability to read and understand patient informed consent form. Patient or their legal representative must sign informed consent form.

Exclusion Criteria:

1) Presence of diffuse leptomeningeal disease, or gliomatosis cerebri

2) Systemic corticosteriod therapy > 2 mg of dexamethasone or equivalent per day at study enrollment

3) Active systemic infection requiring treatment, including any HIV infection. An infection controlled by therapy is not an exclusion provided it is not consistent with exclusion criterion 4

4) Known medical condition that, in the opinion of the Investigator, would compromise the patient's ability to participate in the study. This would include chronic active hepatitis infection, known immunosuppressive disease or concurrent neurodengenerative disease

5) Patients who have undergone stereotactic radiosurgery prior to or following surgical resection, or the placement of Gliadel Wafers

6) Women who are pregnant or lactating

7) Evidence of current drug or alcohol abuse

8) Use of any experimental drug for any reason within 60 days prior to enrollment

9) Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins

10) A second site of disease (such as a lesion in the alternate hemisphere)

Links

Registration Number: NCT00458601
Study Information on Clinical Trials Registry (clinicaltrials.gov)