A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma
Rationale: This is a Phase 2 study of folate-hapten conjugate therapy in combination with
low-doses of the cytokines Interleukin-2 (IL-2) and Interferon-alpha (INF-alpha).
Folate-hapten conjugate 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 receptor is
over-expressed in many human cancers, including renal cell carcinoma. It is expected that
EC17 will attach to cancer cells through the folate 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. During the screening period, all potential patients
will undergo imaging with 99mTc-EC20 (a technetium-based, folate- linked radiopharmaceutical
[EC20]) for the purpose of identifying patients whose tumors express the folate receptor;
the target of folate-hapten conjugate therapy. Prior to receiving EC90/GPI-0100 and EC17
therapy, patients must exhibit at least one tumor lesion that displays adequate uptake of
99mTc-EC20 during the imaging procedure.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate - the proportion of subjects with objective response based on RECIST criteria
A minimum of 13 weeks (time to first follow-up CT)
No
Richard A Messmann, MD, MHS, BSc
Study Director
Endocyte
United States: Food and Drug Administration
EC-FI-004
NCT00485563
June 2007
March 2009
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
The Methodist Hospital Research Institute | Houston, Texas 77030 |