Colorectal Cancer, Liver Cancer, Locally Advanced Tumor, Melanoma, Metastatic Solid Tissue Tumors, Pancreatic Cancer
Conditions
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.
Interventions
BIOLOGICALDCVax-Direct
Autologous, activated dendritic cells for intratumoral injection
Sponsors
Northwest Biotherapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
(summary): * Age between 18 and 75 years (inclusive) at screening. * Karnofsky performance status (KPS) of 70 or higher or Eastern Cooperative Oncology Group (ECOG) 0-1 at screening. * 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. * Not eligible for complete resection due to either tumor location, physician's assessment or subject's choice. * 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. * Any steroid therapy \>2 mg dexamethasone or equivalent dose should be stopped or have been tapered down 2 weeks prior to the leukapheresis. * 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. * Adequate hematological, hepatic, and renal function, * Adequate blood coagulation parameters * Life expectation of \>3 months.
Exclusion criteria
(Summary): * Positive HIV-1, HIV-2, or Human T-lymphotropic virus (HTLV-I/II) tests. * 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. * Heavily pretreated (HP) subjects are not eligible for this study, unless treatments have occurred more than 1 year in the past. * 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. * History of immunodeficiency or unresolved autoimmune disease. * Requirement for ongoing immunosuppressants. * Prior active immunotherapy for cancer within the past 2 years. * Ongoing medical need for continuous anti-coagulation or anti-platelet medication. * Known genetic cancer-susceptibility syndromes. * Acute or active uncontrolled infection * Ongoing fever ≥ 101.5 degrees F/38.6 degrees C at screening. * Unstable or severe intercurrent medical conditions such as 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 (surgical, hormonal or double barrier, i.e. condom and diaphragm). * Allergy or anaphylaxis to any of the reagents used in this study. * Inability to obtain informed consent because of psychiatric or complicating medical problems. * Inability or unwillingness to return for required visits and follow-up exams.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with tumor response | 18 months |
Other
| Measure | Time frame |
|---|---|
| Number of patients surviving | 24 months |
| Number of patients surviving without tumor progression | 24 months |
Countries
United States
Outcome results
None listed