Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsors and Collaborators:	Duke University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00639639

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
Brain and Central Nervous System Tumors	Drug: tetanus toxoid Drug: therapeutic autologous dendritic cells Drug: therapeutic autologous lymphocytes	Phase I

MedlinePlus related topics: Cancer Cytomegalovirus Infections

Drug Information available for: Temozolomide Tetanus Vaccine

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Feasibility and safety of vaccination with cytomegalovirus pp65-LAMP mRNA-loaded dendritic cells (DCs) with or without autologous lymphocyte transfer [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Humoral and cellular immune responses [ Designated as safety issue: No ]
Time to 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 [ 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 [ Designated as safety issue: No ]
Immunologic cell infiltrate in recurrent tumors [ Designated as safety issue: No ]
Evidence of antigen-escape outgrowth in recurrent or progressive tumors [ Designated as safety issue: No ]

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
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.	Drug: therapeutic autologous dendritic cells Given intradermally Drug: therapeutic autologous lymphocytes Given IV
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.	Drug: therapeutic autologous dendritic cells Given intradermally
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.	Drug: therapeutic autologous dendritic cells Given intradermally
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.	Drug: tetanus toxoid Given by injection Drug: therapeutic autologous dendritic cells Given intradermally

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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

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

Locations

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

Sponsors and Collaborators

Duke University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Duane Mitchell, MD, PhD

Duke University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):

adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 16, 2009