ClinicalTrials.gov
History of Changes for Study: NCT00045968
Study of a Drug [DCVax(TM)-Brain(Elu)] to Treat Brain Cancer
Latest version (submitted May 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 September 20, 2005 Recruitment Status, Study Status, Study Identification, Eligibility, Study Description, Contacts/Locations, Outcome Measures, Study Design and Conditions
3 September 22, 2005 Outcome Measures, Study Description and Study Status
4 October 31, 2005 Conditions, Study Description and Study Status
5 November 4, 2005 Study Description and Study Status
6 December 15, 2006 Recruitment Status, Contacts/Locations, Study Status, Outcome Measures, Study Design, Conditions, Study Description, Study Identification, Eligibility and Oversight
7 March 20, 2007 Contacts/Locations and Study Status
8 June 11, 2007 Contacts/Locations, Study Status and Study Design
9 July 20, 2007 Contacts/Locations and Study Status
10 May 6, 2008 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Design, Study Status, Study Identification, Eligibility, Oversight and Sponsor/Collaborators
11 July 9, 2008 Contacts/Locations and Study Status
12 July 21, 2008 Contacts/Locations and Study Status
13 August 5, 2008 Contacts/Locations and Study Status
14 October 23, 2008 Contacts/Locations and Study Status
15 June 9, 2009 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
16 March 24, 2011 Study Description, Study Status and Study Design
17 April 18, 2011 Recruitment Status, Contacts/Locations, Study Status and Eligibility
18 April 28, 2011 Contacts/Locations and Study Status
19 May 3, 2011 Contacts/Locations and Study Status
20 May 25, 2011 Contacts/Locations and Study Status
21 June 23, 2011 Contacts/Locations and Study Status
22 July 5, 2011 Study Status and Contacts/Locations
23 July 21, 2011 Contacts/Locations and Study Status
24 July 29, 2011 Contacts/Locations and Study Status
25 August 6, 2011 Contacts/Locations and Study Status
26 September 19, 2011 Contacts/Locations, Outcome Measures, Sponsor/Collaborators, Arms and Interventions, Conditions, Study Description, Study Status and Study Identification
27 September 28, 2011 Contacts/Locations and Study Status
28 October 4, 2011 Study Status and Contacts/Locations
29 November 15, 2011 Study Status and Contacts/Locations
30 November 30, 2011 Contacts/Locations and Study Status
31 December 15, 2011 Study Status and Contacts/Locations
32 December 27, 2011 Contacts/Locations and Study Status
33 December 29, 2011 Contacts/Locations and Study Status
34 December 30, 2011 Contacts/Locations and Study Status
35 January 3, 2012 Study Status and Contacts/Locations
36 January 10, 2012 Contacts/Locations and Study Status
37 January 20, 2012 Eligibility and Study Status
38 February 6, 2012 Study Status and Contacts/Locations
39 February 7, 2012 Contacts/Locations and Study Status
40 February 17, 2012 Contacts/Locations and Study Status
41 April 4, 2012 Conditions and Study Status
42 May 17, 2012 Contacts/Locations, Study Design, Study Status, Study Description, Eligibility and Study Identification
43 June 4, 2012 Contacts/Locations and Study Status
44 June 18, 2012 Contacts/Locations and Study Status
45 July 23, 2012 Contacts/Locations and Study Status
46 August 16, 2012 Contacts/Locations and Study Status
47 September 12, 2012 Contacts/Locations and Study Status
48 November 15, 2012 Study Status and Contacts/Locations
49 February 6, 2013 Study Status and Contacts/Locations
50 March 27, 2013 Contacts/Locations and Study Status
51 May 16, 2013 Contacts/Locations and Study Status
52 May 31, 2013 Contacts/Locations and Study Status
53 July 24, 2013 Contacts/Locations and Study Status
54 August 7, 2013 Contacts/Locations and Study Status
55 October 7, 2013 Study Status and Contacts/Locations
56 October 8, 2013 Contacts/Locations and Study Status
57 October 11, 2013 Contacts/Locations and Study Status
58 December 2, 2013 Contacts/Locations and Study Status
59 March 14, 2014 Contacts/Locations and Study Status
60 April 17, 2014 Contacts/Locations and Study Status
61 April 21, 2014 Contacts/Locations and Study Status
62 April 29, 2014 Contacts/Locations and Study Status
63 June 9, 2014 Study Status and Contacts/Locations
64 June 12, 2014 Contacts/Locations and Study Status
65 October 20, 2014 Contacts/Locations and Study Status
66 October 30, 2014 Contacts/Locations and Study Status
67 November 10, 2014 Contacts/Locations and Study Status
68 December 1, 2014 Contacts/Locations and Study Status
69 December 2, 2014 Contacts/Locations and Study Status
70 January 7, 2015 Study Status and Contacts/Locations
71 February 12, 2015 Contacts/Locations and Study Status
72 February 13, 2015 Contacts/Locations and Study Status
73 February 23, 2015 Contacts/Locations and Study Status
74 February 24, 2015 Contacts/Locations and Study Status
75 February 25, 2015 Contacts/Locations and Study Status
76 March 6, 2015 Study Status and Contacts/Locations
77 April 8, 2015 Contacts/Locations and Study Status
78 April 17, 2015 Study Status and Contacts/Locations
79 April 21, 2015 Contacts/Locations and Study Status
80 May 1, 2015 Study Status and Contacts/Locations
81 May 6, 2015 Contacts/Locations and Study Status
82 May 13, 2015 Contacts/Locations and Study Status
83 May 19, 2015 Contacts/Locations and Study Status
84 May 22, 2015 Contacts/Locations and Study Status
85 June 9, 2015 Study Status and Contacts/Locations
86 June 26, 2015 Contacts/Locations and Study Status
87 July 7, 2015 Contacts/Locations and Study Status
88 July 22, 2015 Contacts/Locations and Study Status
89 July 30, 2015 Contacts/Locations and Study Status
90 August 20, 2015 Contacts/Locations and Study Status
91 August 24, 2015 Contacts/Locations and Study Status
92 August 26, 2015 Contacts/Locations and Study Status
93 August 27, 2015 Contacts/Locations and Study Status
94 August 28, 2015 Contacts/Locations and Study Status
95 August 31, 2015 Contacts/Locations and Study Status
96 October 6, 2015 Study Status
97 October 8, 2015 Contacts/Locations, Study Design and Study Status
98 October 28, 2015 Contacts/Locations and Study Status
99 October 29, 2015 Recruitment Status, Contacts/Locations and Study Status
100 January 11, 2016 Study Status and Contacts/Locations
101 February 22, 2016 Study Status and Contacts/Locations
102 February 25, 2016 Study Status
103 October 12, 2016 Study Status
104 May 12, 2022 Outcome Measures, Study Status, Study Description and Contacts/Locations
Comparison Format:
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Study NCT00045968
Submitted Date:  June 23, 2005 (v1)
Open or close this module Study Identification
Unique Protocol ID: DC2-GBM(elu), June 2002
Brief Title: Study of a Drug [DCVax(TM)-Brain(Elu)] to Treat Brain Cancer
Official Title: A Phase II Clinical Trial Evaluating DCVax(TM)-Brain(Elu), Autologous Dendritic Cells Pulsed with Autologous Glioblastoma Multiforme (GBM) Acid-Eluted Tumor Antigens for the Treatment of GBM
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2002
Overall Status: Suspended
Study Start:
Primary Completion:
Study Completion:
First Submitted: September 17, 2002
First Submitted that
Met QC Criteria:		 September 18, 2002
First Posted: September 19, 2002 [Estimate]
Last Update Submitted that
Met QC Criteria:		 June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Northwest Biotherapeutics
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(TM)-Brain(elu) in patients with GBM after surgical resection and radiation therapy.
Detailed Description:

This Phase II trial is designed to evaluate the safety, clinical response and survival of study subjects following treatment with DCVax(TM)-Brain(elu), an immunotherapy intervention for glioblastoma multiforme. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize brain cancer cells. This may help the immune system destroy brain cancer cells. Side effects reported from the Phase I trial include skin reactions of redness, pain & swelling at the injection site, nausea/vomiting, headache & fatigue, diarrhea & low-grade fever.

Full details on this Phase II clinical trial are available in the informed consent.
Open or close this module Conditions
Conditions: Glioblastoma Multiforme
Keywords: oncology
neurology
glioblastoma multiforme
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 90
Open or close this module Arms and Interventions
Intervention Details:
Drug: Dendritic cell immunotherapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria

  • Eighteen (18) years or older.
  • Newly diagnosed GBM or recurrent brain tumor now with GBM that have not received radiation or chemotherapy.
  • Surgically resectable tumor; histologically verified GBM.
  • Must complete radiation therapy 2 weeks prior to experimental therapy.
  • Karnofsky performance score (KPS) of >60.
  • No antitumor drug therapies until 4 wks after 3rd and last injection of DCVax(TM)-Brain(elu).
  • Adequate hematological, hepatic and renal function.
  • No history of prior malignancy.

Exclusion Criteria

  • Rapid disease progression between surgical resection and baseline.
  • History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV.
  • Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers).
  • Previous cytotoxic or non-cytotoxic drug therapies.
  • Acute infection within 7 days prior to study treatment.
  • Pregnant or lactating females.
  • Unstable or severe intercurrent medical conditions.
  • Subjects with organ allografts or any underlying conditions that contraindicate DCVax(TM)-Brain(elu) treatment.
  • Inability to obtain informed consent because of psychiatric or medical problems.
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Northwest Biotherapeutics, Inc.
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services