Malignant Neoplasms of Brain Clinical Trial
Official title:
Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00643097 -
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT00639639 -
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 1 |