Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (ATTAC)
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ClinicalTrials.gov Identifier: NCT00639639 |
Recruitment Status :
Active, not recruiting
First Posted : March 20, 2008
Last Update Posted : March 3, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Malignant Neoplasms of Brain | Biological: tetanus toxoid Biological: therapeutic autologous dendritic cells Biological: therapeutic autologous lymphocytes | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-induced Lymphopenia |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | April 15, 2017 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
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Experimental: Arm I (first randomization)
Patients receive CMV-ALT IV over 45-90 minutes (course 1 only) and CMV pp65-LAMP mRNA-loaded DC (CMV-DC) vaccine intradermally and administered in equal portions to each inguinal region. Vaccination repeats every 1-3 weeks for up to 3 doses in the absence of unacceptable toxicity.
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Biological: therapeutic autologous dendritic cells
Given intradermally Biological: therapeutic autologous lymphocytes Given IV |
Experimental: Arm II (first randomization)
Patients receive CMV-DC vaccine intradermally and administered in equal portions to each inguinal region. Vaccination repeats every 1-3 weeks for up to 3 doses in the absence of unacceptable toxicity.
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Biological: therapeutic autologous dendritic cells
Given intradermally |
Experimental: Arm I (second randomization)
Within 6 to 24 hours prior to vaccination, patients undergo skin site preparation with unpulsed DCs at the vaccination site in one inguinal region. Patients then receive indium In 111-labeled CMV-DC.
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Biological: therapeutic autologous dendritic cells
Given intradermally |
Experimental: Arm II (second randomization)
Within 6 to 24 hours prior to vaccination, patients undergo vaccination skin site preparation in the opposite inguinal region with tetanus toxoid. Patients then receive 111 In-labeled CMV-DC.
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Biological: tetanus toxoid
Given by injection Biological: therapeutic autologous dendritic cells Given intradermally |
- Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer [ Time Frame: 26 months ]
- Humoral and cellular immune responses [ Time Frame: 26 months ]
- Time to progression [ Time Frame: From time of surgery/diagnosis to date of progression. ]
- Differential ability of indium In-111-labeled DCs to track to the inguinal lymph nodes under different skin preparative conditions [ Time Frame: At vaccine # 4 ]
- 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 [ Time Frame: At vaccine # 4 ]
- Immunologic cell infiltrate in recurrent tumors [ Time Frame: At progression ]
- Evidence of antigen-escape outgrowth in recurrent or progressive tumors [ Time Frame: At progression ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histopathologic diagnosis of glioblastoma multiforme
- Newly diagnosed WHO grade IV disease
- Underwent definitive resection within the past 4 weeks
- Residual radiographic contrast enhancement on post-resection CT scan or MRI must not exceed 1 cm in diameter in two perpendicular axial planes
- No radiographic or cytologic evidence of leptomeningeal or multicentric disease at any time prior to vaccination
PATIENT CHARACTERISTICS:
- Karnofsky performance status 80-100%
- Curran Group status I-IV
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring treatment
- No unexplained febrile (> 101.5º F) illness
- No known immunosuppressive disease
- No known HIV infection
- No unstable or severe intercurrent medical conditions such as severe heart or lung disease
- No demonstrated allergy or intolerance to temozolomide for reasons other than lymphopenia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior conventional antitumor therapy other than steroids, radiotherapy, or temozolomide
- No prior inguinal lymph node dissection
- No prior radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies
- No concurrent corticosteroids, with the exception of nasal or inhaled steroids, at a dose above physiologic levels (defined as < 2 mg of dexamethasone/day)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639639
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Katherine Peters, MD, PhD | Duke Univeristy Medical Center |
Responsible Party: | Gary Archer Ph.D., Assistant Professor Neurosurgery, Duke University |
ClinicalTrials.gov Identifier: | NCT00639639 |
Other Study ID Numbers: |
Pro00003877 CDR0000589624 ( Other Identifier: National Cancer Institute ) DUMC-8108-07-1R1 ( Other Identifier: Legacy Duke IRB number ) Discretionary Funds ( Other Identifier: DUMC ) |
First Posted: | March 20, 2008 Key Record Dates |
Last Update Posted: | March 3, 2022 |
Last Verified: | March 2022 |
adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Neoplasms Brain Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |