GEN2 Directed Cancer Immunotherapy Trial

Korábbi kezelés

• Concurrent therapy with anticancer agent including any other investigational agent.
• Pregnant or breast-feeding women. Female patients must agree to use effective contraception, must be surgically sterile or must be post-menopausal. Male patients must agree to use effective contraception or be surgically sterile. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate. All at-risk female patients must have a negative pregnancy test within 7 days prior to start of the study treatment.
• Patients must not be taking steroids at the time of screening. Last dose of steroids must be >7 days.

Más betegség

• Clinically significant cardiac disease (New York Heart Associate, Class III or IV)
• Dementia or altered mental status that would prohibit informed consent.
• Patients who are known to be HIV positive.

Laborértékek

• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study.

Egyéb

• Existing intracranial edema or CVA within 6 months of screening
• Known side effects to antivirals in the ganciclovir class

• Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumor(2) in the liver that are refractory to standard therapy or for which no curative standard therapy exists.
• Evidence of radiographically measurable or evaluation disease on a baseline PET-CT scan.
• All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures must have resolved to National Cancer Institute (NCI) Common Toxicity Criteria (CTC) (Version 4.03) Grade < 1.
• Patient must be legally considered an adult in the country in which they are participating in the study.
• Last dose of antineoplastic therapy, except for hormonal therapy, must be > 21 days. External beam radiotherapy must have been <25% bone marrow-containing skeleton.
• Patients may be Hepatitis B and C positive.
• Patients may have intracranial metastases of any number if they have been brain irradiated and stable for 6 weeks. Patients may be taking anti-seizure medicines but must not be on steroids. Last dose of steroids must be >7 days.
• Karnofsky performance status must be > or = 70
• Childs-Pugh Classification Score of 7 or less
• Life Expectancy of at least 3 months
• Patients must be able to travel to alternate medical center for PET/CT scans, if necessary.
• Meet the required baseline laboratory data
• Signed informed consent indicating that they are aware of the neoplastic nature of their disease and have been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts.
• Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.