Study of CD133KDEL Toxin in the Treatment for Solid Tumors

Inclusion Criteria

• •1. Pathologically or cytologically confirmed, metastatic or unresectable solid tumor malignancy.
• •2. Measurable or evaluable disease per RECIST 1.1 criteria (Appendix II), or modified RECIST criteria for mesothelioma (Appendix II).
• •3. At least 1 prior line of systemic therapy considered standard for the malignancy, and for which no standard therapies exist. Prior systemic chemotherapy, immunotherapy, biological therapy, radiation therapy and/or surgery are allowed before the first dose of dCD133KDEL with the following restrictions:
• •* At least 14 days since any systemic therapy.
• •* At least 28 days since any experimental therapy.
• •* At least 14 days since any radiation therapy.
• •* At least 28 days since any major surgery, defined as a surgery involving a risk to the life of the patient, specifically, an operation upon an organ within the cranium, chest, abdomen, or pelvic cavity.
• •4. Recovered from the acute toxic effects (≤ grade 1, CTCAE v4.0) of previous cancer treatment prior to study registration.
• •5. ECOG performance status 0 or 1 (Appendix III).
• •6. Adequate organ function within 14 days of study registration, defined as follows System Parameter Laboratory Value Hematologic Absolute neutrophil count (ANC) ≥1.5 x 10\^9 /L Hemoglobin\* 9 g/dL Platelets\* ≥100 x 10\^9 /L Hepatic Total bilirubin \< 2 x ULN\^ ALT \< 2 x ULN\^ Renal Serum creatinine \< 1.5 mg/dL OR estimated GFR \>50 by modified Cockcroft-Gault (\* Patient may not have had a transfusion within 7 days
• •\^ Upper limit of institutional normal.)
• •7. Albumin ≥ 3.0 gm/dL within 14 days of study registration.
• •8. Adequate cardiac function, defined as an ejection fraction ≥40% on transthoracic echocardiogram done within 14 days of study registration.
• •10. Adequate pulmonary function, defined as resting oxygen saturation ≥ 90% on room air and/or pulmonary function tests (PFT) showing corrected DLCO \>50% and FEV1 ≥ 2 liters or ≥ 60% of predicted. PFT testing is required within 28 days of study registration only if the patient is symptomatic or prior known impairment is present.
• •11. Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraception methods, one of which must be a barrier method, during the study and for ≥12 weeks after the last dose of dCD133KDEL. Effective methods include intrauterine device (IUD), Depo-Provera injection or implant, Evra patch, NuvaRing, oral contraception, and diaphragm/spermicide with condom.
• •12. Ability to understand and provide voluntary written consent.