Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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

Inclusion Criteria:

- Have a histologically confirmed diagnosis of metastatic or refractory cancer for
which there are no effective standard therapeutic options available, (Note: for
patients accrued at Southern Illinois University, a diagnosis of renal (i.e., kidney)
carcinoma is required.)

- Have signed an Institutional Review Board (IRB) approved informed consent form (ICF)
prior to performing any study evaluation/procedures

- Be > or = 18 years of age and women must either be 1) not of childbearing potential
or 2) have a negative serum pregnancy test within 7 days prior to commencing
treatment. Patients are considered not of childbearing potential if they are
surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or
bilateral oophorectomy) or they are postmenopausal (12 consecutive months of
amenorrhea [lack of menstruation])

- (If applicable) Have completed prior cytotoxic chemotherapy, radiotherapy or
immunotherapy or experimental therapy > or = 30 days prior to the study enrollment,
and recovered form associated toxicities

- Have an Eastern Cooperative Oncology Group (ECOG) score of < or = 2, and an
anticipated life expectancy of at least 6 months

- Have adequate hematologic function, as defined by an absolute or calculated
neutrophil count > or = 1500/microL, platelet count > or = 100000/microL, lymphocyte
count > or = 500/microL, and hemoglobin level > or = 10 g/dL. Patients may not
receive prophylactic transfusion in order to qualify for trial eligibility

- Have adequate renal function, as defined by a documented serum creatinine of < or =
2.0mg/dL. Greater than "1+" proteinuria will require microscope evaluation and the
results discussed with the medical monitor prior to patient enrollment; or if serum
creatine is >2.0, patient must have an actual or calculated 24-hour creatinine
clearance of >60mL/min and no obvious evidence of concurrent medullary cystic disease
or obstructive uropathy

- Have adequate hepatic function, as defined by a total bilirubin level < or = 1.5 x
upper limit of normal (ULN) and alkaline phosphatase, aspartate transaminase (AST),
and alanine transaminase (ALT) levels < or = 2.5 x ULN. If alkaline phosphatase is
outside of these parameters and is due to bone metastases (as verified by the
assessment of isoenzymes), then the patient is eligible.

Exclusion Criteria:

- Have previously participated in a FolateImmune trial

- Have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to
fluorescein or any drug, radiologic contrast agent, insect bite, food, cytokines, or
any other agent; or have received fluorescein within 30 days of the study.

- Have medical conditions that preclude the use of IL-2 or IFN-alpha. These conditions
include but are not limited to, diabetes mellitus with a history of progression to
diabetic ketoacidosis, history of severe coagulation disorder, psoriasis,
sarcoidosis, retinal hemorrhage, symptomatic pulmonary disease, heart failure (> or =
New York Heart Association NYHA class II), or transplant requiring immunosuppressive

- Be pregnant or breast-feeding

- Be currently receiving an experimental drug, or used an experimental device within 30
days of study entry

- Be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy
with immunosuppressant agents

- Have any concomitant malignancy with the exception of basal cell or squamous cell
carcinoma of skin

- 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)

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

Initial dose of study therapy through 30 days post last dose of study therapy

Safety Issue:


Principal Investigator

Richard A Messmann, MD, MHS, BSc

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

June 2008

Related Keywords:

  • Cancer
  • Cancer
  • Vaccine
  • Phase I
  • FolateImmune
  • Recurrent
  • Refractory
  • Experimental
  • Neoplasm Metastasis



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