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Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (ATTAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Sampson, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00639639
First received: March 19, 2008
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

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

Secondary Outcome Measures:
  • Humoral and cellular immune responses [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: From time of surgery/diagnosis to date of progression. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Immunologic cell infiltrate in recurrent tumors [ Time Frame: At progression ] [ Designated as safety issue: No ]
  • Evidence of antigen-escape outgrowth in recurrent or progressive tumors [ Time Frame: At progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: January 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639639

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
John Sampson
Investigators
Principal Investigator: Gordana Vlahovic, MD Duke Univeristy Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: John Sampson, Professor of Neurosurgery, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00639639     History of Changes
Other Study ID Numbers: Pro00003877, CDR0000589624, DUMC-8108-07-1R1, Discretionary Funds
Study First Received: March 19, 2008
Last Updated: November 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Neoplasms
Astrocytoma
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 19, 2014