A Phase I Study of EC90 With GPI-0100 Adjuvant Followed by EC17 With Cytokines (Interleukin-2 [IL-2] and Interferon-alpha [IFN-alpha]) in Patients With Refractory or Metastatic Cancer
Rationale: This is a Phase 1b, single-cohort study of FolateImmune in combination with
low-doses of the cytokines Interleukin-2 (IL-2) and Interferon-alpha (IFN-alpha).
FolateImmune treatment consists of subcutaneous vaccinations with EC90, a compound designed
to elicit an immune response (antibodies) to a dye called fluorescein (FITC), in combination
with GPI-0100 adjuvant (a drug intended to improve antibody production). Vaccination is
followed by treatment with EC17, a drug made by linking folate (a vitamin) with FITC.
Experimental evidence has shown that the folate vitamin receptor is over-expressed in many
human cancers. It is expected that EC17 will attach to cancer cells through the folate
vitamin receptor and that antibodies to FITC will recognize the cancer cell and mark it for
destruction by the body's immune system. Two drugs, IL-2 and IFN-alpha, will be
administered at low doses in combination with EC17 in order to boost the immune response.
- Evaluate the safety of administering EC90 vaccine with GPI-0100 adjuvant.
- Evaluate the safety of administering EC17 concurrent with IL-2 and IFN-alpha
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Initial dose of study therapy through 30 days post last dose of study therapy
Richard A Messmann, MD, MHS, BSc
United States: Food and Drug Administration
|Southern Illinois University School of Medicine||Springfield, Illinois 62794-9658|
|The Methodist Hospital||Houston, Texas 77030|
|Great Lakes Cancer Institute Breslin Cancer Center||Lansing, Michigan 48910|