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

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ClinicalTrials.gov Identifier: NCT00045968
Recruitment Status : Unknown
Verified October 2016 by Northwest Biotherapeutics.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2002
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Northwest Biotherapeutics

Tracking Information
First Submitted Date  ICMJE September 17, 2002
First Posted Date  ICMJE September 19, 2002
Last Update Posted Date October 14, 2016
Study Start Date  ICMJE December 2006
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00045968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2011)
The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients. [ Time Frame: Until Death ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer
Official Title  ICMJE A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)
Brief Summary The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm 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 III trial is designed to evaluate the impact on disease progression and survival time, as well as safety, in 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. Eligible patients will receive a series of injections of DCVax-L, to activate and then boost the immune response to the tumor cells.

The primary study endpoint is PFS (progression free survival), and the first secondary endpoint is overall survival (OS). Other endpoints include performance status, immune response, and also safety. Interim analyses to assess efficacy are incorporated in the trial design.

Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain & swelling at the injection site.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma Multiforme
  • Glioblastoma
  • GBM
  • Grade IV Astrocytoma
  • Glioma
  • Brain Cancer
  • Brain Tumor
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: treatment cohort
    Intervention: Drug: Dendritic cell immunotherapy
  • Placebo Comparator: Placebo Chohort
    Autologous PBMC
    Intervention: Drug: Dendritic cell immunotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 8, 2015)
348
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
90
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations 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 not have progressive disease at completion of radiation therapy. Patients with suspected pseudoprogression will be enrolled and analyzed separately.
  • 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-L. DCVax-L 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00045968
Other Study ID Numbers  ICMJE 020221
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwest Biotherapeutics
Study Sponsor  ICMJE Northwest Biotherapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Linda Liau, M.D. University of California, Los Angeles
Study Director: Marnix L. Bosch, MBA, PhD Northwest Biotherapeutics
PRS Account Northwest Biotherapeutics
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP