Personalized cancer vaccine trial halted early – what we know

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient must be ≥18 years of age. 2. Stage I-IV patients. 3. Demonstrated tolerance of maintenance or adjuvant immunotherapy, targeted therapy, and/or hormonal therapy for three doses (if maintenance therapy is indicated) 4. ECOG 0-1 performance. 5. Patient must have a predicted life expectancy of ≥ 6 months. 6. No uncontrolled or life-threatening health conditions. 7. No active, acute infections 8. Patient must have the following laboratory values (obtained ≤28 days prior to enrollment): 1. Serum creatinine \<2 × upper limit of normal (ULN) or if higher than normal range, calculated creatinine clearance (CrCL) must be ≥30 mL/min/1.73 m2; actual body weight must be used for CrCL unless BMI \>30 kg/m2 then lean body weight must be used. 2. Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN). 3. AST and ALT ≤2.5 × ULN, or ≤5 × ULN if due to liver involvement by tumor. 4. Hemoglobin ≥9.0 g/dL. 5. Platelets ≥100 × 109 cells/L. 6. Absolute neutrophil count ≥1.5 ×109 cells/L (without the use of hematopoietic growth factors). 7. Corrected QT interval (QTc) \<470 ms for females and \<450 ms for males (as calculated by the Fridericia correction formula). 9. Completion of standard adjuvant therapy to include chemotherapy, radiation therapy, and/or other immunosuppressive therapy as clinically indicated. 10. Women of childbearing potential (WOCBP) and males with female partners of child- bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last inoculation. 11. Patient must have a site of disease with planned incisional or excisional procedure expected to result in sufficient tissue for vaccine creation, or must be amenable to biopsy and be a candidate for tumor biopsy with anticipated sufficient tumor tissue resulting to vaccine creation. Exclusion Criteria: 1. Steroids, immunosuppressive therapy (to include mTOR inhibitors), or cytotoxic chemotherapy within 30 days of enrollment. 2. Involved in other clinical trials. 3. ECOG ≥2 4. Pregnancy and/or breast feeding. 5. Untreated or progressing brain metastases. Treated stable brain metastases that have not progressed for at least 3 months will be permitted at the PI's discretion. 6. Rapidly progressive disease or visceral crisis 7. Patient has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time 8. Patient has a diagnosis of immunodeficiency, either primary or acquired. 9. Patient has current second malignancy at other sites (exceptions: nonmelanomatous skin cancer, adequately treated in situ carcinoma \[e.g., cervical\], or indolent prostate cancer under observation). A history of other malignancies is allowed as long as patient has been free of recurrence for ≥2 years, or if the patient has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence. 10. Patient has active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or HIV (testing not required). 11. Patient has received live vaccines within the past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date \>30 days prior to administration of TLPO). 12. History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of \>Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed. 13. Patient has any medical or social condition that, in the opinion of the Investigator, might place a patient at increased risk, affect compliance, or confound safety or other clinical study data interpretation.