Status:
COMPLETED
Basiliximab in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Targeted Immunotherapy and Temozolomide-Caused Lymphopenia
Lead Sponsor:
Gary Archer Ph.D.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasms Brain
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: 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...
Detailed Description
OBJECTIVES: Primary * To determine if basiliximab inhibits the functional and numeric recovery of T-regulatory cells after therapeutic temozolomide (TMZ)-induced lymphopenia in the context of vaccin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histopathologically confirmed glioblastoma multiforme
- WHO grade IV disease
- Must undergo leukapheresis ≤ 4 weeks after definitive resection
- Residual radiographic contrast enhancement on post-resection CT scan or MRI must not exceed 1 cm in diameter in two perpendicular axial planes
- Patients with evidence of contrast enhancement exceeding 1 cm in diameter in two perpendicular axial planes after radiation will not be a candidate for the vaccine despite being previously enrolled and will be removed from the study and replaced
- No radiographic or cytologic evidence of leptomeningeal or multicentric disease
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Curran Group status I-IV
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring treatment
- No unexplained febrile (\>101.5°F) illness
- No known immunosuppressive disease or known HIV infection
- No unstable or severe intercurrent medical conditions such as severe heart or lung disease
- No allergy to temozolomide (TMZ) or otherwise unable to tolerate TMZ for reasons other than lymphopenia
- Patients who are found after enrollment to be unable to tolerate TMZ will not be a candidate for the vaccine despite being previously enrolled and will be removed from the study and replaced
- No prior allergic reaction to daclizumab or one of its components
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior daclizumab
- No other prior conventional therapeutic intervention except for steroids, radiation, or temozolomide
- No prior inguinal lymph node dissection, radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies
- No concurrent corticosteroids, with the exception of nasal or inhaled steroids, at a dose above physiologic levels
- Patients requiring an increase in corticosteroids, with the exception of nasal or inhaled steroids, such that at the time of first vaccination they require a dose above physiologic levels, will be removed from the study and replaced (physiologic dose will be defined as \< 2 mg of dexamethasone/day)
- Once vaccinations have been initiated, if patients subsequently require increased steroids, they will still be permitted to remain on the study, but every effort will be made to minimize steroid requirements
- No prior allogeneic solid organ transplantation
Exclusion
Key Trial Info
Start Date :
April 24 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00626483
Start Date
April 24 2007
End Date
July 6 2016
Last Update
March 9 2021
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710