Malignant Neoplasms of Brain Clinical Trial
— ATTACOfficial title:
Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-induced Lymphopenia
Verified date | March 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | June 1, 2022 |
Est. primary completion date | April 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Gary Archer Ph.D. | National Cancer Institute (NCI) |
United States,
Batich KA, Reap EA, Archer GE, Sanchez-Perez L, Nair SK, Schmittling RJ, Norberg P, Xie W, Herndon JE 2nd, Healy P, McLendon RE, Friedman AH, Friedman HS, Bigner D, Vlahovic G, Mitchell DA, Sampson JH. Long-term Survival in Glioblastoma with Cytomegalovir — View Citation
Mitchell DA, Batich KA, Gunn MD, Huang MN, Sanchez-Perez L, Nair SK, Congdon KL, Reap EA, Archer GE, Desjardins A, Friedman AH, Friedman HS, Herndon JE 2nd, Coan A, McLendon RE, Reardon DA, Vredenburgh JJ, Bigner DD, Sampson JH. Tetanus toxoid and CCL3 im — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer | 26 months | ||
Secondary | Humoral and cellular immune responses | 26 months | ||
Secondary | Time to progression | From time of surgery/diagnosis to date of progression. | ||
Secondary | Differential ability of indium In-111-labeled DCs to track to the inguinal lymph nodes under different skin preparative conditions | At vaccine # 4 | ||
Secondary | Differential ability of indium In-111-labeled DCs to track to lymph nodes on the tumor bearing and non-tumor bearing side of the cervical lymph nodes | At vaccine # 4 | ||
Secondary | Immunologic cell infiltrate in recurrent tumors | At progression | ||
Secondary | Evidence of antigen-escape outgrowth in recurrent or progressive tumors | At progression |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00643097 -
Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00626015 -
Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery
|
Phase 1 |