Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00626483 : Basiliximab in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Targeted Immunotherapy and Temozolomide-Caused Lymphopenia
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00626483      |      Link to official Clinicaltrials.gov listing
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