Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT00693095
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years of age.
* GBM (WHO Grade IV) with definitive resection \<4 weeks prior to leukapheresis with residual radiographic contrast enhancement on post-resection CT or MRI of \<1 cm in maximal diameter in any axial plane.
* Karnofsky Performance Status (KPS ) of \> 80% and a Curran Group status of I-IV.
Exclusion Criteria:
* Radiographic or cytologic evidence of leptomeningeal or multicentric disease at any time prior to vaccination.
* Prior conventional anti-tumor therapy other than steroids, RT, or TMZ.
* Pregnant or need to breast feed during the study period (Negative b-HCG test required).
* Requirement for continuous corticosteroids above physiologic levels at time of first vaccination.
* Active infection requiring treatment or an unexplained febrile (\> 101.5o F) illness.
* Known immunosuppressive disease or human immunodeficiency virus infection.
* Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease.
* Allergic or unable to tolerate TMZ for reasons other than lymphopenia.
* Patients with previous inguinal lymph node dissection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00693095
Study Brief:
Protocol Section:
NCT00693095