Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer (GBM)
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| ClinicalTrials.gov Identifier: NCT00045968 |
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Recruitment Status :
Active, not recruiting
First Posted : September 19, 2002
Last Update Posted : May 18, 2022
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Sponsor:
Northwest Biotherapeutics
Information provided by (Responsible Party):
Northwest Biotherapeutics
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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. All patients 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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma Multiforme Glioblastoma GBM Grade IV Astrocytoma Glioma Brain Cancer Brain Tumor | Drug: Dendritic cell immunotherapy | Phase 3 |
This Phase III trial is designed to evaluate the impact on 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 OS (overall survival) compared to external controls in newly diagnosed glioblastoma, and the first secondary endpoint is OS compared to external controls in recurrent glioblastoma.
Side effects reported from early trials are mostly mild, and may include skin reactions of redness, pain & swelling at the injection site.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 348 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM) |
| Study Start Date : | December 2006 |
| Estimated Primary Completion Date : | November 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Brain Tumors
| Arm | Intervention/treatment |
|---|---|
| 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:
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Placebo Comparator: Placebo Chohort
Autologous PBMC
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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:
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Primary Outcome Measures :
- 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 newly diagnosed glioblastoma. [ Time Frame: Until death ]
Secondary Outcome Measures :
- 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 comparable, contemporaneous clinical trials, in recurrent GBM. [ Time Frame: Until death ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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. 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045968
Locations
Show 86 study locations
Sponsors and Collaborators
Northwest Biotherapeutics
Investigators
| Principal Investigator: | Linda Liau, M.D. | University of California, Los Angeles | |
| Study Director: | Marnix L. Bosch, MBA, PhD | Northwest Biotherapeutics |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Northwest Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT00045968 |
| Other Study ID Numbers: |
020221 |
| First Posted: | September 19, 2002 Key Record Dates |
| Last Update Posted: | May 18, 2022 |
| Last Verified: | May 2022 |
Keywords provided by Northwest Biotherapeutics:
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oncology neurology glioma brain tumor brain cancer 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 |
Additional relevant MeSH terms:
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Glioblastoma Brain Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Immunomodulating Agents Immunologic Factors Physiological Effects of Drugs |