safety and efficacy study of dcvax-direct in solid tumors

Conditions: Locally Advanced Tumor; Metastatic Solid Tissue Tumors; Liver Cancer; Colorectal Cancer; Pancreatic Cancer; Melanoma

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.


Eligibility criteria:
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.