Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gradalis, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 the injectate.
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 alopecia.
6. 1 measurable or evaluable lesion; ≥ 1.8 cm diameter for cohort 1 (see Table 10); injection and biopsy accessible.
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.
You may not be if
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 \>/=1 month.
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 study requirements.
8. Patients who are pregnant or nursing.
9. Patients with known HIV.
10. Patients with chronic Hepatitis B and C infection.
