Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-induced Lymphopenia

Pro00003877

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 temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with radiation therapy and chemotherapy may kill more cancer cells. PURPOSE: This randomized phase I/II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme recovering from lymphopenia caused by temozolomide.

2006-02-06

2017-04-15

2022-06-01

Completed

Early phase I

42

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}

2023-03-13