Status:
COMPLETED
Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery
Lead Sponsor:
John Sampson
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasms of Brain
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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 ...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00626015
Start Date
March 1 2007
End Date
February 1 2013
Last Update
January 21 2016
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710