Status:
COMPLETED
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
Gary Archer Ph.D.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasms of Brain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines may help the body build an effective immune response to kill cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy, such as temoz...
Detailed Description
OBJECTIVES: Primary * To evaluate the feasibility and safety of vaccination with cytomegalovirus (CMV) pp65-lysosomal-associated membrane protein (LAMP) mRNA-loaded dendritic cells (DCs) during reco...
Eligibility Criteria
Inclusion
- Age \>18 years of age.
- World Health Organization (WHO) Grade IV glioma with definitive resection prior to leukapheresis with residual radiographic contrast enhancement on most recent 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 the time of enrollment.
- Prior conventional anti-tumor therapy other than steroids, RT, Avastin or TMZ.
- Pregnant or need to breast feed during the study period (Negative Beta-Human Chorionic Gonadotrophin \[HCG\] 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 :
February 6 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00639639
Start Date
February 6 2006
End Date
June 1 2022
Last Update
March 13 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710