Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme

NCT00323115 | Completed Phase 2 Results

• 1 other identifier: D0536
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

immunotherapy; cancer vaccine; glioblastoma multiforme

Outcome Measures

Primary Outcomes (1)

• Tumor-specific Cytotoxic T-cell Response

  MRI \& pheresis post vaccine

  Day 42

Secondary Outcomes (13)

• Number of Adverse Events: Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination

  Until death or approximately 24 months after diagnosis

• Number of Participants With Evaluable Data: Feasibility of Vaccination

  Through enrollment, approximately 2 years

• Progression Free Survival (PFS)

  Approximately 42 months

• Number of Participants With Significant Difference in Tumor Volume Size Pre- and Postvaccination: Neuroimaging and Tumor Assessment

  baseline and 4 weeks

• Overall Survival Duration: Efficacy Parameters

  Approximately 42 months

Study Arms (1)

Vaccine

EXPERIMENTAL

Biological: Autologous Dendritic Cell; Drug: Temozolomide; Procedure: Radiotherapy; Biological: Dendritic Cell Vaccine

Interventions

Autologous Dendritic Cell BIOLOGICAL

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

Vaccine

Temozolomide DRUG

Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC

Vaccine

Radiotherapy PROCEDURE

RT is standard of care (SOC) post surgery

Vaccine

Dendritic Cell Vaccine BIOLOGICAL

Vaccine given cervical lymphnode injection 3 times every other week

Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical Center (DHMC)
• Tumor specimen obtained at the time of surgery adequate for vaccination
• years of age or older
• Karnofsky Performance Status 60% or greater
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L
• Platelets greater than or equal to 100 x 10 9th/L
• Aspartate Aminotransferase (AST) or Alanine Aminotransferase (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

You may not qualify if:

• Invasive cancers in the past 5 years
• Rheumatologic/autoimmune disease
• Pregnancy or unwillingness to remain on acceptable form of birth control during study
• Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

• Fadul CE, Fisher JL, Hampton TH, Lallana EC, Li Z, Gui J, Szczepiorkowski ZM, Tosteson TD, Rhodes CH, Wishart HA, Lewis LD, Ernstoff MS. Immune response in patients with newly diagnosed glioblastoma multiforme treated with intranodal autologous tumor lysate-dendritic cell vaccination after radiation chemotherapy. J Immunother. 2011 May;34(4):382-9. doi: 10.1097/CJI.0b013e318215e300.

  PMID: 21499132 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Results Point of Contact

• Title: Dr. Camilo Fadul
• Organization: Dartmouth-Hitchcock Medical Center

camilo.e.fadul@hitchcock.org

603-653-6312

Study Officials

• Camilo E. Fadul, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2006
• First Posted: May 9, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: July 1, 2013
• Last Updated: October 10, 2018
• Results First Posted: September 26, 2012

Record last verified: 2018-10

Locations

US (1)