Status:
COMPLETED
Evaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer
Lead Sponsor:
John Sampson
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to learn if your own immune cells can be activated and multiplied in order to help your body fight off the tumor cells in your brain. The safety of this procedure...
Detailed Description
Six CMV seropositive patients with newly-diagnosed GBM will be randomized to receive CMV-ALT (3 x 107/Kg) with or without vaccine with CMV-DCs (2 x 107). All patients will undergo a leukapheresis afte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00693095
Start Date
September 1 2008
End Date
April 1 2015
Last Update
January 30 2018
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710