Phase I Trial of Intratumoral Bi-functional shRNA Stathmin 1-knockdown Lipoplex in Patients With Advanced and/or Metastatic Cancer
1. Histologically confirmed advanced and/or metastatic cancer, and, if limited to a
single lesion, not considered a candidate for curative surgery or radiation therapy).
2. Biopsy accessible lesion.
3. Per cohort dose/volume, the volume of the lesion to be injected must be 3x volume of
4. Subjects that have completed all acceptable therapies with curative potential that
are the current standard of care for their respective diseases.
5. Recovered from all toxicities (≤ Grade 1) related to prior therapies except for
6. 1 measurable or evaluable lesion; ≥ 1.8 cm diameter for cohort 1 (see Table 10);
injection and biopsy accessible.
7. Age ≥18 years.
8. ECOG performance status (PS) 0-2.
9. 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
10. 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.
11. Negative pregnancy test.
1. Surgery involving general anesthesia, chemotherapy, radiotherapy, or immunotherapy
within 3 weeks prior to entering the study.
2. Patient must not have received any other investigational agents within 4 weeks prior
to study entry.
3. 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
4. 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.
5. Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission
for >/= 2 years.
6. Kaposi's Sarcoma.
7. 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
8. Patients who are pregnant or nursing.
9. Patients with known HIV.
10. Patients with chronic Hepatitis B and C infection.
11. Patients with uncontrolled diseases.