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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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ClinicalTrials.gov Identifier: NCT00626015
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 21, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Sampson, Duke University

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as basiliximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving chemotherapy, radiation therapy, and vaccine therapy together with basiliximab is a more effective treatment for glioblastoma multiforme than chemotherapy, radiation therapy, and vaccine therapy alone.

PURPOSE: This randomized phase I trial is studying the side effects and best way to give chemotherapy and radiation therapy followed by vaccine therapy with basiliximab in treating patients with glioblastoma multiforme that has been removed by surgery.

Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Brain Biological: PEP-3-KLH conjugate vaccine Biological: daclizumab Drug: temozolomide Other: placebo Biological: PEP-3-KLH Phase 1

Detailed Description:



  • To determine if basiliximab inhibits the functional and numeric recovery of T-regulatory cells (Tregs) after therapeutic temozolomide (TMZ)-induced lymphopenia in the context of vaccinating adult patients with newly diagnosed glioblastoma multiforme (GBM) using PEPvIII-keyhole limpet hemocyanin (KLH).


  • To evaluate the safety of basiliximab in the context of vaccinating adult patients with newly diagnosed GBM using PEP-3-KLH conjugate vaccine during recovery from therapeutic TMZ-induced lymphopenia.
  • To determine if basiliximab enhances the magnitude or character of PEPvIII-KLH-induced cellular or humoral immune responses, inhibits or enhances activation-induced cell death, or induces immunologic or clinical evidence of autoimmunity.
  • To determine if basiliximab enhances the magnitude or character of PEPvIII-KLH-induced cellular or humoral immune responses, inhibits or enhances activation-induced cell death, or induces immunologic or clinical evidence of autoimmunity.
  • To determine if basiliximab alters the phenotype (CD56-expression), cytokine secretion profile, or cytotoxicity of CD3-negative CD56-positive natural killer cells.
  • To determine if basiliximab, in addition to vaccination, extend progression-free survival compared to historical cohorts.
  • To characterize immunologic cell infiltrate in recurrent tumors and seek evidence of antigen escape outgrowth.


  • Leukapheresis: Patients undergo leukapheresis over 2-4 hours for immunologic monitoring.
  • Concurrent standard adjuvant chemoradiotherapy: Patients receive external-beam radiotherapy once daily, 5 days a week, over 6-7 weeks (33 fractions) and concurrent temozolomide by mouth 7 days a week for up to 49 days beginning on the first day and continuing until the last day of radiotherapy.
  • Temozolomide and PEP-3-KLH conjugate vaccine: Approximately 3 weeks after completion of radiotherapy, patients receive temozolomide by mouth on days 1-21, or on days 1-5 depending on their treating neuro-oncologist, basiliximab IV over 30 minutes on day 21, and PEP-3-KLH conjugate vaccine intradermally on days 21, 35, and 49.

Patients then receive a second course of temozolomide by mouth on days 1-21 or days 1-5, depending on their treating neuro-oncologist. Treatment with temozolomide repeats every 4 weeks for 5 additional courses. Patients also receive PEP-3-KLH conjugate vaccine on day 21 of each remaining temozolomide course. Patients then receive the vaccine monthly until disease progression.

Patients undergo blood sample collection periodically for laboratory studies.

After completion of study therapy, patients are followed periodically.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]
Study Start Date : March 2007
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines
Drug Information available for: Daclizumab

Arm Intervention/treatment
Experimental: Arm I
Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab
Biological: PEP-3-KLH conjugate vaccine
Given intradermally

Biological: daclizumab
Given IV

Drug: temozolomide
Given by mouth.

Experimental: Arm II
Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline
Biological: PEP-3-KLH conjugate vaccine
Given intradermally

Drug: temozolomide
Given by mouth.

Other: placebo
Given IV

Experimental: Basiliximab
Patients will receive basiliximab 20 mg IV with vaccine # 1 only and continue with PEP-3-KLH, temozolomide.
Biological: PEP-3-KLH
Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only.
Other Names:
  • CDX-110

Primary Outcome Measures :
  1. Functional suppressive capacity of CD4+CD25+CD127- T-regulatory cells [ Time Frame: 26 months ]
  2. Comparison of proliferative T-cell response to phytohemagglutinin (PHA) among treatment groups (with versus without daclizumab/basiliximab) [ Time Frame: 26 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626015

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
John Sampson
National Cancer Institute (NCI)
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Principal Investigator: Duane Mitchell, MD, PhD Duke University
Publications of Results:
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Responsible Party: John Sampson, Professor of Neurosurgery, Duke University
ClinicalTrials.gov Identifier: NCT00626015    
Other Study ID Numbers: Pro00000947
R21CA132891 ( U.S. NIH Grant/Contract )
CDR0000579573 ( Other Identifier: National Cancer Institute )
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by John Sampson, Duke University:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
adult high grade glioma
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs