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Safety and Tolerability Study of FolateImmune in Combination With Cytokines in Patients With Refractory or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329368
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a Phase 1b clinical trial to assess the safety and tolerability of vaccination with EC90 (KLH-FITC) and GPI-0100 (adjuvant) followed by treatment with EC17 (Folate-FITC) in combination with low-dose cytokines (IL-2 and IFN-alpha) in patients with metastatic or refractory cancer.

Condition or disease Intervention/treatment Phase
Cancer Biological: EC90 (KLH-FITC) Biological: GPI-0100 Drug: EC17 (Folate-FITC) Drug: Interleukin-2 Drug: Interferon-alpha Phase 1

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : June 2008

Intervention Details:
  • Biological: EC90 (KLH-FITC)
    1.2mg in combination with adjuvant GPI-0100 administered subcutaneously, weekly for 4 consecutive weeks during the first treatment cycle, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
    Other Name: Keyhole limpet hemocyanin fluorescein
  • Biological: GPI-0100
    3.0mg in combination with EC90 administered subcutaneously weekly for 4 consecutive weeks during the first treatment cycle, weekly for 2 consecutive weeks during the second cycle and once for each additional cycle.
    Other Name: Saponin-based adjuvant
  • Drug: EC17 (Folate-FITC)
    0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks followed by 2 observation weeks for each cycle.
    Other Names:
    • folate-fluorescein conjugate
    • folate-hapten conjugate
  • Drug: Interleukin-2
    Low dose (7-12 MIU) IL-2 administered subcutaneously three times per week (MWF) for 3 consecutive weeks during the first cycle, 4 consecutive weeks during cycle 2 and additional cycles
    Other Names:
    • IL-2
    • Proleukin
  • Drug: Interferon-alpha
    3.0 MIU administered subcutaneously 3 times per week (MWF) for 3 consecutive weeks during the first cycle of treatment, then 3.0 MIU administered subcutaneously 3 times per week (MWF) for 4 weeks for cycle 2 and additional cycles.
    Other Names:
    • IFN-alpha
    • Intron-A

Primary Outcome Measures :
  1. Safety [ Time Frame: Initial dose of study therapy through 30 days post last dose of study therapy ]
  2. Tolerability [ Time Frame: Initial dose of study therapy through 30 days post last dose of study therapy ]
  3. Anti-tumor Activity [ Time Frame: From initial dose of study therapy to disease progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 therapy
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329368

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United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
United States, Michigan
Great Lakes Cancer Institute Breslin Cancer Center
Lansing, Michigan, United States, 48910
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
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Study Director: Richard A Messmann, MD, MHS, BSc Endocyte

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Responsible Party: Endocyte Identifier: NCT00329368     History of Changes
Other Study ID Numbers: EC-FI-003
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Endocyte:
Phase I

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Interferon alpha-2
Keyhole-limpet hemocyanin
Folic Acid
Vitamin B Complex
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Growth Substances
Adjuvants, Immunologic