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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 : November 14, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Archer Ph.D., Duke University

Study Description
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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 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
Malignant Neoplasms of Brain Biological: tetanus toxoid Biological: therapeutic autologous dendritic cells Biological: therapeutic autologous lymphocytes Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 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.
 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.
 Biological: tetanus toxoid
Given by injection

Biological: therapeutic autologous dendritic cells
Given intradermally


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer [ Time Frame: 26 months ]

Secondary Outcome Measures :
  1. Humoral and cellular immune responses [ Time Frame: 26 months ]
  2. Time to progression [ Time Frame: From time of surgery/diagnosis to date of progression. ]
  3. 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 ]
  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 ]
  5. Immunologic cell infiltrate in recurrent tumors [ Time Frame: At progression ]
  6. Evidence of antigen-escape outgrowth in recurrent or progressive tumors [ Time Frame: At progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Gary Archer Ph.D.
National Cancer Institute (NCI)
Investigators
Principal Investigator: Katherine Peters, MD, PhD Duke Univeristy Medical Center
More Information
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Publications of Results:

Responsible Party: Gary Archer Ph.D., Assistant Professor Neurosurgery, Duke University
ClinicalTrials.gov Identifier: NCT00639639     History of Changes
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: November 14, 2018
Last Verified: November 2018

Keywords provided by Gary Archer Ph.D., Duke University:
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs