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CompletedNCT00626015ZAP ITUpdated Jan 21, 2016

Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery

A Phase 1 interventional study of PEP-3-KLH conjugate vaccine and daclizumab in Malignant Neoplasms of Brain, sponsored by John Sampson. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-01-21.

Sponsored by John Sampson · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • 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).

Secondary

  • 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.

OUTLINE:

  • 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.

02

Conditions studied

  • Malignant Neoplasms of Brain

Keywords

  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult high grade glioma
03

In context

Glioblastoma

1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.

This study's enrollment of 16 is below the median of 36 across 1,645 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

John Sampson is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Arm I

    Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab

    Biological: PEP-3-KLH conjugate vaccine · Biological: daclizumab · Drug: temozolomide

  • Experimental
    Arm II

    Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline

    Biological: PEP-3-KLH conjugate vaccine · Drug: temozolomide · Other: placebo

  • Experimental
    Basiliximab

    Patients will receive basiliximab 20 mg IV with vaccine # 1 only and continue with PEP-3-KLH, temozolomide.

    Biological: PEP-3-KLH

Interventions

  • BiologicalPEP-3-KLH conjugate vaccine

    Given intradermally

  • Biologicaldaclizumab

    Given IV

  • Drugtemozolomide

    Given by mouth.

  • Otherplacebo

    Given IV

  • BiologicalPEP-3-KLH

    Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only.

    Also known as: CDX-110, EGFRvIII-KLH

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Publications

  • Sampson JH, Schmittling RJ, Archer GE, Congdon KL, Nair SK, Reap EA, Desjardins A, Friedman AH, Friedman HS, Herndon JE 2nd, Coan A, McLendon RE, Reardon DA, Vredenburgh JJ, Bigner DD, Mitchell DA. A pilot study of IL-2Ralpha blockade during lymphopenia depletes regulatory T-cells and correlates with enhanced immunity in patients with glioblastoma. PLoS One. 2012;7(2):e31046. doi: 10.1371/journal.pone.0031046. Epub 2012 Feb 27. PubMed 22383993 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2007, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2008
First posted
Feb 29, 2008
Start
Mar 2007
Primary completionActual
Feb 2013
CompletionActual
Feb 2013
Last update
Jan 21, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00626015
Lead sponsor
John Sampson
Collaborators
National Cancer Institute (NCI)
Responsible party
John Sampson (Professor of Neurosurgery, Duke University) — Sponsor-investigator
First posted
Feb 29, 2008
Start date
Mar 2007
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Jan 21, 2016

Study contacts

Duane Mitchell, MD, PhD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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