Phase I Trial of NHS-IL12 in Subjects With Metastatic Solid Tumors
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James L. Gulley, M.D., Ph.D., F.A.C.P.
Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
1-866-611-6310 (Toll Free)
Mary Pazdur, M.S.N., C.R.N.P
Research Nurse Practitioner
Research Nurse Specialist
Key Eligibility Criteria:
- Histologically or cytologically proven metastatic or locally advanced solid epithelial or mesenchymal tumors, except unstable brain metastases
- Standard curative or palliative measures do not exist or are no longer effective
- ≥ 18 years of age
- Adequate organ function as defined by liver, kidney, and hematologic laboratory testing
- No acquired immune defects, systemic autoimmune disease, history of organ transplant, history of chronic infections, or history of active inflammatory bowel disease
- Screening with physical examination and blood samples to determine eligibility for the study
- Admission to the clinical center for at least one day
- Study drug NHS-IL12 as a one-time subcutaneous injection (a shot under the skin)
- Monitoring of blood pressure, temperature, heart rate, and breathing
- Blood samples will be taken before and numerous times after administration of NHS-IL12
- Clinic visit 28 days after receiving the dose of NHS-IL12 with complete physical examination and blood draws
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.