Dok, I hope that is not the case. The company told us the initial going would be slow as the FDA wants to see careful establishment of what the dose should be, reaction to it, etc. As well, to best ensure a true test of only DCVax-Direct, the criteria for enrollment is quite stringent (below), so I think it likely the combination of these factors that would cause slow enrollment; that is if it is slow - we really don't know.
Criteria:
Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria (summary):
•Age between 18 and 75 years (inclusive) at screening.
•Karnofsky performance status (KPS) of 60 or higher or Eastern Cooperative Oncology Group (ECOG) 0-2 at screening.
•Patients with a histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential per clinician judgment.
•Not eligible for complete resection due to either, tumor location, physician's assessment or patient's choice.
•Must have completed at least one and no more than four treatment regimens in the metastatic or advanced setting in the disease currently under treatment to reduce tumor burden. Treatment must have been discontinued at least 14 days prior to initiating leukapheresis.
•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 adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
•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.
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