A Clinical Trial Evaluating DCVax®-L, Self-Derived Dendritic Cells Mixed with Tumor Proteins for the Treatment of Glioblastoma, a Type of Brain cancer
- Conditions
- Glioblastoma MultiformeMedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-001977-13-GB
- Lead Sponsor
- orthwest Biotherapeutics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 348
Determined at pre-screening
• Patients =18 and =70 years of age at surgery
• Patients must be able to understand and sign the informed consent. The consent for tumor donation may be signed by a legally authorized representative (LAR) if allowed by the institution.
• Patients must have a life expectancy of =8 weeks determined at or around surgery, and prior to pre-leukapheresis
• Primary therapy must consist of surgical resection with the intent for a gross or near gross total resection of the contrast-enhancing tumor mass as confirmed by central review, followed by external beam radiation therapy and concurrent temozolomide chemotherapy.
• Patients with newly diagnosed, unilateral GBM (Grade IV) without metastases are eligible for this protocol.
• All Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material.
Determined at pre-leukapheresis
• Patients must have adequate bone marrow function (
• Adequate liver function
Determined at baseline (or baseline2 for pseudoprogression patients)
• Patients must have a KPS rating of =70 at the Baseline Visit (Visit 5)
• Patients may have received steroid therapy as part of their primary
treatment. Steroid treatment must preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to 2-4 mg dexamethasone qd at least 7 days prior to the first immunization.
• Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide while being treated with study drug.
• A minimum of 5 immunizations must be available for treatment as determined by the contracted manufacturer.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Determined at pre-screening
• History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 5 or more years prior to Visit 1 (surgery) of
the study.
• History of immunodeficiency disease or unresolved autoimmune disease
• Known HIV-1,2, HTLV-1,2 or Hepatitis B, C infection
• Pregnancy
• Inability to obtain informed consent because of psychiatric or complicating medical problems.
• Any known genetic cancer-susceptibility syndromes.
Determined at or around surgery
• Bilateral or metastatic disease detected at diagnosis, during surgery or at post-surgical magnetic resonance imaging (MRI). Tumors may cross into, but not beyond the corpus callosum.
• Post operative MRI scan evidence of biopsy only without significant tumor resection.
• Implantation of Gliadel® wafers (polifeprosan 20 with carmustine implant) at surgery.
• Positive test(s) for infectious agents (HIV 1 and 2, Anti-HIV-1,2, Hepatitis B, HBsAg, Anti HBc, Hepatitis C, Anti-HCV-Ab, Syphilis) that would preclude eligibility for tumor procurement and processing per manufacturing guidelines.
Determined at pre-leukapheresis
• Positive HIV-1, HIV-2, HTLV-1, 2, hepatitis B surface antigen, or hepatitis C antibody.
• Patients with organ allografts.
• Allergies to reagents used in this study.
• Patients who are unable to stop or taper steroid treatment to less than 8mg of dexamethasone qd prior to leukapheresis
• Inability or unwillingness to return for required visits and follow-up exams.
• Any previous cytotoxic drug therapies for the current disease. *note, cytotoxic therapy received for previous malignancies (resolved greater than 5 years prior) is not excluded
Determined at or prior to baseline
• Patients who have evidence of disease progression (including possible pseudoprogression) as determined by central review are not eligible for the study
• Patients taking medications that might affect immune function and that have documented anti-tumor activity.
• Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy. Antibiotic therapy must be completed at least 7 days prior to the first immunization.
• Active uncontrolled infection e.g. a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
• Fever =101.5oF. If considered possibly transient, retesting is allowed.
• Unstable or severe intercurrent medical conditions e.g., unstable angina, uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
• Females of child-bearing potential who are pregnant or lactating or
who are not using adequate contraception.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses;Secondary Objective: The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence and control patients from<br>comparable, contemporaneous clinical trials, in patients with recurrent GBM. ;Primary end point(s): The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. <br>;Timepoint(s) of evaluation of this end point: October 2020
- Secondary Outcome Measures
Name Time Method