Status:
COMPLETED
Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer
Lead Sponsor:
Gradalis, Inc.
Conditions:
Advanced Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injectio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01505153
Start Date
February 1 2012
End Date
April 13 2017
Last Update
February 22 2018
Active Locations (1)
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1
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230