Safety and Efficacy Study of DCVax-Direct in Solid Tumors
This trial is active, not recruiting.
|Conditions||locally advanced tumor, metastatic solid tissue tumors, liver cancer, colorectal cancer, pancreatic cancer, melanoma|
|Phase||phase 1/phase 2|
|Start date||June 2013|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01882946, NWBio 050012|
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.
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
DCVax-Direct: autologous, activated dendritic cells for intratumoral injection
Number of patients with adverse events
time frame: 6 months
Number of patients with tumor response
time frame: 18 months
Male or female participants from 18 years up to 75 years old.
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.
|Official title||A PHASE I/II CLINICAL TRIAL EVALUATING DCVax-Direct, AUTOLOGOUS ACTIVATED DENDRITIC CELLS FOR INTRATUMORAL INJECTION, IN PATIENTS WITH SOLID TUMORS|
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