Safety and Efficacy Study of DCVax-Direct in Solid Tumors
Study Details
Study Description
Brief Summary
The study comprises a Phase I component during which the optimal dose of DCVax-Direct for the treatment of solid tissue tumors will be identified, followed by a Phase II component to determine if the injection of DCVax-Direct into selected solid tissue tumors has the ability to reduce tumor growth.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCVax-Direct DCVax-Direct: autologous, activated dendritic cells for intratumoral injection |
Biological: DCVax-Direct
Autologous, activated dendritic cells for intratumoral injection
|
Outcome Measures
Primary Outcome Measures
- Number of patients with adverse events [6 months]
Secondary Outcome Measures
- Number of patients with tumor response [18 months]
Other Outcome Measures
- Number of patients surviving [24 months]
- Number of patients surviving without tumor progression [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria (summary):
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Age between 18 and 75 years (inclusive) at screening.
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Karnofsky performance status (KPS) of 70 or higher or Eastern Cooperative Oncology Group (ECOG) 0-1 at screening.
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Subjects with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which primary treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment, with the understanding that DCVax-Direct is not intended as a treatment of last resort.
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Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice.
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Must have completed at least one recent treatment regimen in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden.
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Any steroid therapy >2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis.
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At least one measurable tumor mass, i.e. a lesion that can accurately be measured by CT/MRI in at least one dimension with longest diameter ≥ 1 cm, that is accessible for injection either with or without imaging (CT/ultrasound) guidance.
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Adequate hematological, hepatic, and renal function,
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Adequate blood coagulation parameters
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Life expectation of >3 months.
Exclusion Criteria (Summary):
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Positive HIV-1, HIV-2, or Human T-lymphotropic virus (HTLV-I/II) tests.
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History of current or prior (within the last two years) active clinically significant malignancy other than the tumor type for which DCVax-Direct treatment is considered, and except for primary tumor in the case of metastases and adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
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Heavily pretreated (HP) subjects are not eligible for this study, unless treatments have occurred more than 1 year in the past.
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Presence of brain metastases, unless treated surgically and/or irradiated and clinically stable off steroids or on low dose (< 2 mg per day) steroids for ≥ 14 days, or presence of leptomeningeal disease.
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History of immunodeficiency or unresolved autoimmune disease.
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Requirement for ongoing immunosuppressants.
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Prior active immunotherapy for cancer within the past 2 years.
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Ongoing medical need for continuous anti-coagulation or anti-platelet medication.
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Known genetic cancer-susceptibility syndromes.
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Acute or active uncontrolled infection
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Ongoing fever ≥ 101.5 degrees F/38.6 degrees C at screening.
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Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arrhythmias, Crohn's Disease, ulcerative colitis etc.
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Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm).
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Allergy or anaphylaxis to any of the reagents used in this study.
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Inability to obtain informed consent because of psychiatric or complicating medical problems.
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Inability or unwillingness to return for required visits and follow-up exams.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Health | Orlando | Florida | United States | 32806 |
| 2 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Northwest Biotherapeutics
Investigators
- Study Director: Marnix Bosch, MBA, PhD, Northwest Biotherapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NWBio 050012