Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer

Inclusion criteria

• Histologically confirmed advanced and/or metastatic cancer, and, if limited to a single lesion, not considered a candidate for curative surgery or radiation therapy).
• Biopsy accessible lesion.
• Per cohort dose/volume, the volume of the lesion to be injected must be 3x volume of the injectate.
• Subjects that have completed all acceptable therapies with curative potential that are the current standard of care for their respective diseases.
• Recovered from all toxicities (≤ Grade 1) related to prior therapies except for alopecia.
• 1 measurable or evaluable lesion; ≥ 1.8 cm diameter for cohort 1 (see Table 10); injection and biopsy accessible.
• Age ≥18 years.
• ECOG performance status (PS) 0-2.
• Organ and marrow function as defined below:

Absolute granulocyte count ≥ 1,500/mm^3 Platelets ≥ 100,000/mm^3 Total bilirubin ≤ 1.5x institutional ULN Creatinine ≤ 2.0 mg/dL

• Ability to understand and the willingness to sign a written informed consent document including permission for pre- and Days 1 and 2 post- injection biopsy and Day 8 injected lesion excision.
• Negative pregnancy test.

Exclusion criteria

• Surgery involving general anesthesia, chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to entering the study.
• Patient must not have received any other investigational agents within 4 weeks prior to study entry.
• Patients with known brain metastases unless treated with whole brain radiation and stable for >/= 2 months or treated with stereotactic radiotherapy only and stable for >/=1 month.
• Short term (<30 days) concurrent systemic steroids ≤0.125 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
• Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for >/= 2 years.
• Kaposi's Sarcoma.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients who are pregnant or nursing.
• Patients with known HIV.
• Patients with chronic Hepatitis B and C infection.
• Patients with uncontrolled diseases.