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A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

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.


Inclusion Criteria:



- Must have a histologically confirmed diagnosis of renal cell carcinoma (clear cell or
predominately clear cell component). Papillary histology may also be enrolled
(maximum of 6 patients)

- Must be diagnosed with relapsed or Stage IV disease that is medically or surgically
unresectable and that has progressed after systemic therapy, including at least one
agent in the general class of kinase inhibitors (TKI not required for papillary
histology)

- Must have measurable/evaluable metastatic disease sites that have not previously
received radiotherapy and which does not require palliative intervention (at the time
of enrollment). Patients with non-measurable/evaluable disease are ineligible

- Must have at least one tumor lesion that displays uptake of 99mTc-EC20

- Must be > than or = 18 years of age

- Women must either be 1)not of child-bearing potential of 2)have a negative serum
pregnancy test within 7 days prior to commencing treatment with investigational
agents

- Must have completed prior cytotoxic chemotherapy, radiotherapy, immunotherapy or
experimental therapy 30 or more days prior to study enrollment, and recovered (or
returned to baseline) from associated acute toxicities. This restriction excludes
palliative radiotherapy.

- Must have an ECOG score less than or equal to 2

- Must have adequate hematologic, renal, and heptic function

Exclusion Criteria:

- Must not have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to
fluorescein, radiological contrast agent, cytokines, or have received fluorescein
within 30 days of the study

- Must not have medical conditions that preclude the use of IL-2 or IFN-╬▒.

- Must not be pregnant or breast-feeding

- Must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/or
therapy with immunosuppressant agents

- Must not be currently receiving bisphosphonates such as Zometa® (unless started >
four weeks prior to treatment with EC90/GPI-0100, in which case they can be
continued)

- Must not have any concomitant malignancy with the exception of basal cell or squamous
cell carcinoma of skin

- Must not have radiographically documented evidence of current brain metastases, a
history of stem cell transplant, immunodeficiency, and/or a medical or psychiatric
illness (that in the investigator's opinion, would prevent adequate compliance with
study therapy or evaluation of the endpoints)

- Must not have been administered another radiopharmaceutical that would interfere with
the assessment of 99mTc-EC20

- Must not be unable to tolerate conditions for radionuclide imaging

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate - the proportion of subjects with objective response based on RECIST criteria

Outcome Time Frame:

A minimum of 13 weeks (time to first follow-up CT)

Safety Issue:

No

Principal Investigator

Richard A Messmann, MD, MHS, BSc

Investigator Role:

Study Director

Investigator Affiliation:

Endocyte

Authority:

United States: Food and Drug Administration

Study ID:

EC-FI-004

NCT ID:

NCT00485563

Start Date:

June 2007

Completion Date:

March 2009

Related Keywords:

  • Renal Cell Carcinoma
  • Cancer
  • Vaccine
  • Phase 2
  • folate-hapten conjugate
  • Progressive
  • Metastatic
  • Experimental
  • Carcinoma
  • Carcinoma, Renal Cell

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