Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme - Full Text View

Sponsored by:	Dartmouth-Hitchcock Medical Center
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00323115

Purpose

Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.

Condition	Intervention	Phase
Glioblastoma Multiforme	Biological: Autologous Dendritic Cell Drug: Temozolomide Procedure: Radiotherapy Biological: Dendritic Cell Vaccine	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	DMS-0536: A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

To determine whether intranodal injection of an autologous glioma lysate-derived dendritic cell vaccine will result in a measurable tumor-specific cytotoxic T-cell response [ Time Frame: MRI & pheresis post vaccine ]

Secondary Outcome Measures:

To determine feasibility and toxicity profile of intra-nodal DC/tumor lysate vaccination in this context [ Time Frame: Pheresis ]
To compare the progression free survival and overall survival with prognostic matched historical controls [ Time Frame: PFS will be assessed for each patient as the time from surgery until the patient reaches objective disease progreassion by MRI ]
To correlate the immunological parameters with PFS and overall survival [ Time Frame: Evaluable patients for immunologic parameters are those who have completed 3 vaccines ]
To assess radiological response when there is residual enhancing tumor at baseline MRI [ Time Frame: MRI post vaccine ]

Estimated Enrollment:	10
Study Start Date:	May 2006
Study Completion Date:	April 2008

Intervention Details:

Vaccine given by cervical lymph node injection 3 times every other week

RT with concurrent TMZ for 6 weeks before vaccine is SOC

RT is SOC post surgery

Vaccine given cervical lymphnode injection 3 times every other week

Detailed Description:

Two to six weeks after surgery, patients with newly diagnosed GBM will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). Between three and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. These cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. Vaccinations will be given every two weeks for a total of three vaccinations. Four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically proven GBM with central pathology review at DHMC; Tumor specimen obtained at the time of surgery adequate for vaccination; 18 years of age or older; Karnofsky Performance Status 60% or greater; ANC (neutrophils and bands) greater than or equal to 1.5 x 10 9th/L; Platelets greater than or equal to 100 x 10 9th/L; AST or ALT less than or equal to 5 times the upper limits of normal (ULN); Total bilirubin less than or equal to 1.5 times ULN; Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine clearance greater than or equal to 60 mL/min; No known immunosuppression other than chemo-related; Negative HIV serologies; No evidence of acute or chronic hepatitis on standard hepatitis C and B screening tests; No chemotherapy within four weeks prior to leukapheresis; Radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at DHMC and patient is willing to follow-up per protocol; Off steroids for at least two weeks before leukapheresis; No second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical CIS, superficial bladder cancer or breast CIS; Negative serum or urine pregnancy test for women of childbearing potential; No serious uncontrolled medical disorder or active infection; All patients must give informed consent; No history of clinical evidence of active autoimmune disease

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323115

Locations

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

Principal Investigator:

Camilo E. Fadul, MD

Dartmouth-Hitchcock Medical Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	DMS-0536
Study First Received:	May 4, 2006
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00323115
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:

immunotherapy
cancer vaccine
glioblastoma multiforme

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Glioma
Temozolomide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009