Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21CA132891 | U.S. NIH Grant/Contract | View source | |
| CDR0000579573 | Other Identifier | National Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Secondary
OUTLINE:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Temozolomide, PEP-3-KLH conjugate vaccine, and daclizumab |
|
| Arm II | Experimental | Temozolomide, PEP-3-KLH conjugate vaccine, and normal saline |
|
| Basiliximab | Experimental | Patients will receive basiliximab 20 mg IV with vaccine # 1 only and continue with PEP-3-KLH, temozolomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP-3-KLH conjugate vaccine | Biological | Given intradermally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Functional suppressive capacity of CD4+CD25+CD127- T-regulatory cells | 26 months | |
| Comparison of proliferative T-cell response to phytohemagglutinin (PHA) among treatment groups (with versus without daclizumab/basiliximab) | 26 months |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histopathologic diagnosis of WHO grade III or WHO grade IV high grade glioma
Meets the following criteria:
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:
No demonstrated allergy to TMZ
Able to tolerate TMZ
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
No prior daclizumab/basiliximab
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Duane Mitchell, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22383993 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| daclizumab |
| Biological |
Given IV |
|
| temozolomide | Drug | Given by mouth. |
|
| placebo | Other | Given IV |
|
| PEP-3-KLH | Biological | Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only. |
|
|
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| D000077204 | Temozolomide |
| C558237 | rindopepimut |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided