Malignant Neoplasms of Brain Clinical Trial
— ZAP ITOfficial title:
Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]
Verified date | January 2016 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
John Sampson | National Cancer Institute (NCI) |
United States,
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-2Ra blockade during lymphopenia deple — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional suppressive capacity of CD4+CD25+CD127- T-regulatory cells | 26 months | No | |
Primary | Comparison of proliferative T-cell response to phytohemagglutinin (PHA) among treatment groups (with versus without daclizumab/basiliximab) | 26 months | No |
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 |