History of Changes for Study: NCT00045968

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)

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Study Record Versions

Version	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	Recruitment Status, Study Status, Outcome Measures, Study Description and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	020221
Brief Title:	Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)
Official Title:	A Phase II Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)
Secondary IDs:

Study Status


Record Verification:	January 2012
Overall Status:	Recruiting
Study Start:	December 2006
Primary Completion:	June 2012 [Anticipated]
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:	January 10, 2012
Last Update Posted:	January 12, 2012 [Estimate]

Sponsor/Collaborators


Sponsor:	Northwest Biotherapeutics
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patient must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L and the remaining one third will receive placebo. Patients randomized to placebo will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

Detailed Description:

This Phase II trial is designed to evaluate the safety, clinical response and survival of patients following treatment with DCVax(R)-L, an immunotherapy treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to "teach" the immune system how to recognize brain cancer cells.

Side effects reported from the Phase I trial are mostly mild, and 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.

Conditions


Conditions:	Glioblastoma Multiforme Glioblastoma GBM Grade IV Astrocytoma
Keywords:	oncology neurology glioblastoma multiforme glioblastoma newly diagnosed glioblastoma immunotherapy dendritic cells immune therapy GBM Brain cancer, primary tumor vaccine grade IV astrocytoma DCVax Grade IV brain cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	240 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: treatment cohort	Drug: Dendritic cell immunotherapy Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120. Other Names: DCVax-L DCVax DCVax-Brain
Placebo Comparator: Placebo Chohort Autologous PBMC	Drug: Dendritic cell immunotherapy Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120. Other Names: DCVax-L DCVax DCVax-Brain

Outcome Measures


Primary Outcome Measures:
1.	The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients. [ Time Frame: Time to tumor progression or death ]
Secondary Outcome Measures:
1.	The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients. [ Time Frame: Until Death ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	70 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: All patients must meet the following inclusion criteria. All tests and eligibility criteria must be completed within four weeks of completion of radiation and chemotherapy, following surgery. Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. This determination will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee. Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process. Subjects ≥18 and ≤70 years of age at surgery who are capable of informed consent. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study. Patients must have a life expectancy of >8 weeks. Patients must have a KPS rating of ≥70 at the baseline visit (Visit 3). Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded. These primary treatments must be completed at least two weeks prior to first immunization. Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must be stopped at least 10 days prior to leukapheresis. Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med 352: 987-96, 2005) while being treated with DCVax-Brain. DCVax-Brain treatment must be given as described and temozolomide/Temodar treatment schedules must be given essentially according to the Stupp Protocol. Patients must have adequate bone marrow function (e.g., hemoglobin >10 g/dl, white blood count 3600-11,000mm3, absolute granulocyte count ≥1,500/mm3, absolute lymphocyte count ≥1,000/mm3, and platelet count ≥100K/mm3. Eligibility level of hemoglobin can be reached by transfusion. Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤1.5 times upper limits of normals (ULN) and total bilirubin ≤1.5mg/dl), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy.

Contacts/Locations


Central Contact Person:	Marnix L Bosch, MBA, PhD Telephone: 240-497-9022 Email: marnix@nwbio.com
Study Officials:	Linda Liau, M.D. Principal Investigator University of California, Los Angeles
	Marnix L. Bosch, MBA, PhD Study Director Northwest Biotherapeutics
Locations:	United States, California
	City of Hope [Recruiting] Duarte, California, United States, 91010 Contact:Contact: Anita Kurien, RN 626-256-4673 akurien@coh.org Contact:Principal Investigator: Jana Portnow, MD
	UCLA [Recruiting] Los Angeles, California, United States, 90095 Contact:Contact: Emma Young, R.N. 310-267-2621 elyoung@mednet.ucla.edu Contact:Principal Investigator: Linda Liau, MD, PhD
	Sutter Institute for Medical Research [Recruiting] Sacramento, California, United States, 95816 Contact:Contact: Natalie Marlen, CCRC 916-453-5742 MarlenN@sutterhealth.org Contact:Principal Investigator: Nora Wu, M.D.
	United States, Florida
	H. Lee Moffitt Cancer Center and Research Institute [Active, not recruiting] Tampa, Florida, United States, 33612
	United States, Illinois
	University of Illinois Medical Center [Recruiting] Chicago, Illinois, United States, 60612 Contact:Contact: Karriem Watson, MD MPH MS 312-355-0334 kswatson@uic.edu Contact:Principal Investigator: Herbert Engelhard, MD
	Illinois Cancer Care [Recruiting] Peoria, Illinois, United States, 61615 Contact:Contact: Jordan Clum, CCRP 309-243-3620 jclum@illinoiscancercare.com Contact:Principal Investigator: Paul Fishkin, MD
	United States, Michigan
	University of Michigan, Department of Neurosurgery [Recruiting] Ann Arbor, Michigan, United States, 48109 Contact:Contact: Jason Heth, M.D. 734-615-4486 Contact:Principal Investigator: Jason Heth, M.D.
	Henry Ford Hospital [Recruiting] Detroit, Michigan, United States, 48202 Contact:Contact: Amy Williamson, RN 313-916-3731 awillia1@hfhs.org Contact:Principal Investigator: Tom Mikkelsen, MD
	United States, Minnesota
	Virginia Piper Cancer Institute [Recruiting] Minneapolis, Minnesota, United States, 55407 Contact:Contact: Nilanjana Banerji 612-262-4837 Ext. na.Baner Nilanjana.Banerji@allina.com Contact:Principal Investigator: John Trusheim, M.D.
	United States, Missouri
	St. Luke's Hospital [Recruiting] Kansas City, Missouri, United States, 64111 Contact:Contact: Jennifer McIntire, RN 816-932-7985 jmcintire@saintlukes.org Contact:Principal Investigator: Michael Salacz, MD
	Washington University School of Medicine [Recruiting] St. Louis, Missouri, United States, 63110 Contact:Contact: Chloe Fournier, RN 314-362-3165 cfournie@dom.wustl.edu Contact:Principal Investigator: David Tran, MD, PhD
	United States, New Jersey
	Overlook Hospital [Recruiting] Summit, New Jersey, United States, 07902 Contact:Contact: Patricia Eagan, RN 908-522-5914 pat.eagan@atlantichealth.org Contact:Principal Investigator: Michael L Gruber, MD
	United States, New York
	Long Island Brain Tumor Centre at Neurological Surgery P.C. [Recruiting] Commack, Great Neck, New York, United States, 11021 Contact:Contact: Kimberly Prabhu, MA, CCRP 631-864-3900 kprabhu@nspc.com Contact:Principal Investigator: Jai Grewal, MD
	Huntington Hospital [Recruiting] Huntington, New York, United States, 11743 Contact:Contact: Kimberly Prabhu, MA, CCRC 516-478-0010 kprabhu@nspc.com
	North Shore University Hospital [Recruiting] Manhasset, New York, United States, 11030 Contact:Contact: Kimberly Prabhu, MA, CCRP 516-478-0010 kprabhu@nspc.com
	Winthrop University Hospital [Recruiting] Mineola, New York, United States, 11501 Contact:Contact: Kimberky Prabhu 516-478-0010 kprabhu@nspc.com Contact:Principal Investigator: Jai Grewal, MD
	New York University Clinical Cancer Center [Recruiting] New York, New York, United States, 10016 Contact:Contact: Brian Beardslee, RN, MSN 212-731-5404 Brian.Beardslee@nyumc.org Contact:Principal Investigator: Michael L Gruber, MD
	South Nassau Community Hospital [Recruiting] Oceanside, New York, United States, 11572 Contact:Contact: Kimberly Prabhu, MA, CCRC 516-478-0010 kprabhu@nspc.com
	University of Rochester Medical Center [Recruiting] Rochester, New York, United States, 14642 Contact:Contact: Jacqueline Behr 585-276-3581 Jacqueline_Peet@URMC.Rochester.edu Contact:Principal Investigator: Kevin Walter, MD
	Mercy Medical Center [Recruiting] Rockville Centre, New York, United States, 11571-9024 Contact:Contact: Kimberly Prabhu, MA, CCRC 516-478-0010 kprabhu@nspc.com
	Brain and Spine Surgeons of New York and Northern Westchester Hospital [Recruiting] White Plains, New York, United States, 10604 Contact:Contact: Jan Strack, RN 914-517-7982 jstrack@bssny.com Contact:Principal Investigator: John Abrahams, MD
	United States, Ohio
	UC Cancer Institute [Recruiting] Cincinnati, Ohio, United States, 45267 Contact:Contact: Suzanne Sifri, RN, BSN 513-584-0618 suzanne.sifri@uc.edu Contact:Principal Investigator: Olivier Rixe, MD
	University Hospitals of Cleveland [Recruiting] Cleveland, Ohio, United States, 44106 Contact:Contact: Henry Krzemien, RN 216-983-3021 Henry.krzemien@uhhospitals.org Contact:Principal Investigator: Andrew E. Sloan, MD
	United States, Tennessee
	St. Thomas Hospital [Recruiting] Nashville, Tennessee, United States, 37205 Contact:Contact: Nancy Grimes, RN 615-222-4356 Ngrimes@stthomas.org Contact:Principal Investigator: Steve Abram, MD
	United States, Texas
	Baylor Research Institute [Recruiting] Dallas, Texas, United States, 75246 Contact:Contact: Pamela Kurian, M.S. 214-820-8685 Pamela.Kurian@baylorhealth.edu Contact:Principal Investigator: Karen Fink, MD, PhD
	United States, Washington
	Swedish Hospital Neuroscience Research [Recruiting] Seattle, Washington, United States, 98122 Contact:Contact: Nathan Hansen 206-320-3542 Nathan.Hansen@swedish.org Contact:Principal Investigator: Greg Foltz, MD

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References


Links:	URL: http://www.nwbio.com Description: Northwest Biotherapeutics, Inc.
Available IPD/Information: