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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00639639 |
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 |
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Brain and Central Nervous System Tumors |
Drug: tetanus toxoid Drug: therapeutic autologous dendritic cells Drug: therapeutic autologous lymphocytes |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-Induced Lymphopenia |
Estimated Enrollment: | 16 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (first randomization): Experimental
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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Drug: therapeutic autologous dendritic cells
Given intradermally
Drug: therapeutic autologous lymphocytes
Given IV
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Arm II (first randomization): Experimental
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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Drug: therapeutic autologous dendritic cells
Given intradermally
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Arm I (second randomization): Experimental
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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Drug: therapeutic autologous dendritic cells
Given intradermally
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Arm II (second randomization): Experimental
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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Drug: tetanus toxoid
Given by injection
Drug: therapeutic autologous dendritic cells
Given intradermally
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histopathologic diagnosis of glioblastoma multiforme
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 |
Principal Investigator: | Duane Mitchell, MD, PhD | Duke University |
Study ID Numbers: | CDR0000589624, DUMC-PRO00003877, DUMC-8108-07-1R1, NCI-09-C-0038 |
Study First Received: | March 19, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00639639 |
Health Authority: | Unspecified |
adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Lymphopenia Central Nervous System Neoplasms Temozolomide Cytomegalovirus Neuroectodermal Tumors Glioblastoma multiforme |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Cytomegalovirus Infections Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Nervous System Diseases Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |