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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT00626015 |
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Date of registration:
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28/02/2008 |
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Primary sponsor: |
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Public title:
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Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery
ZAP IT |
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Scientific title:
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Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT] |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00626015 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Duane Mitchell, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histopathologic diagnosis of WHO grade III or WHO grade IV high grade glioma
- Newly diagnosed disease
- Meets the following criteria:
- The patient must undergo leukapheresis for immunologic monitoring
- Tumor expression of EGFRvIII by immunohistochemistry (IHC) or polymerase chain
reaction (PCR)
- No radiographic or cytologic evidence of leptomeningeal or multicentric disease
PATIENT CHARACTERISTICS:
- Karnofsky performance status = 80%
- Curran Group status of I-IV
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No conditions that will potentially confound the study results, including any of the
following:
- Active infection requiring treatment or an unexplained febrile (> 101.5°F)
illness
- Known immunosuppressive disease or known HIV infection
- Unstable or severe intercurrent medical conditions such as severe heart or lung
disease
- No demonstrated allergy to TMZ
- Able to tolerate TMZ
- TMZ-induced lymphopenia allowed
- No prior allergic reaction to daclizumab/basiliximab or its components
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other conventional therapeutic intervention other than steroids, radiation, or
temozolomide (TMZ) prior to enrollment
- No prior allogeneic solid organ transplantation
- No prior inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled
monoclonal antibodies
- No corticosteroids at a dose above physiologic level except nasal or inhaled steroid
at the time of first study vaccination
- For the purposes of this study, physiologic dose is defined as < 2 mg of
dexamethasone/day
- Once study vaccinations have been initiated, if patients subsequently require
increased steroids, they are permitted to remain on the study
- No prior daclizumab/basiliximab
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malignant Neoplasms of Brain
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Intervention(s)
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Biological: daclizumab
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Biological: PEP-3-KLH
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Biological: PEP-3-KLH conjugate vaccine
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Drug: temozolomide
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Other: placebo
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Primary Outcome(s)
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Comparison of proliferative T-cell response to phytohemagglutinin (PHA) among treatment groups (with versus without daclizumab/basiliximab)
[Time Frame: 26 months]
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Functional suppressive capacity of CD4+CD25+CD127- T-regulatory cells
[Time Frame: 26 months]
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Secondary ID(s)
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CDR0000579573
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Pro00000947
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R21CA132891
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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