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Sponsored by: |
Endocyte |
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Information provided by: | Endocyte |
ClinicalTrials.gov Identifier: | NCT00485563 |
This is a Phase 2 clinical trial to collect data on tumor responses produced by folate-hapten conjugate therapy (vaccination with EC90 [KLH-FITC] and GPI-0100 adjuvant followed by treatment with EC17 (folate-FITC) in combination with low-dose cytokines in patients with progressive metastatic renal cell carcinoma. All patients will undergo imaging with the investigational imaging agent 99mTc-EC20 (FolateScan) during the screening period to confirm eligibility for the treatment portion of the clinical trial.
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Biological: EC90 (KLH-FITC) Biological: GPI-0100 Drug: EC17 (Folate-FITC) Drug: Interleukin-2 Drug: Interferon-alpha |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of EC17 (Folate-Hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 47 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
University of Nebraska Medical Center | Completed |
Omaha, Nebraska, United States, 68198-7680 | |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Kevin Barga, RN 201-336-8017 kbarga@humed.com | |
Principal Investigator: Robert Alter, MD | |
United States, Texas | |
The Methodist Hospital Research Institute | Terminated |
Houston, Texas, United States, 77030 |
Study Director: | Richard A Messmann, MD, MHS, BSc | Endocyte |
Responsible Party: | Vice President, Medical Affairs Endocyte, Inc. ( Richard A. Messmann MD MHS MSc ) |
Study ID Numbers: | EC-FI-004 |
Study First Received: | June 11, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00485563 |
Health Authority: | United States: Food and Drug Administration |
Cancer Vaccine Phase 2 folate-hapten conjugate |
Progressive Metastatic Experimental |
Interferon-alpha Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Keyhole-limpet hemocyanin Carcinoma Folic Acid Aldesleukin |
Urologic Diseases Interleukin-2 Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Interferon Alfa-2b Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hematologic Agents Neoplasms by Site Sensory System Agents Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Analgesics |
Neoplasms by Histologic Type Vitamin B Complex Hematinics Growth Substances Adjuvants, Immunologic Angiogenesis Inhibitors Antiviral Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Central Nervous System Agents |