Status:
COMPLETED
Safety and Tolerability Study of FolateImmune in Combination With Cytokines in Patients With Refractory or Metastatic Cancer
Lead Sponsor:
Endocyte
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 lo...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00329368
Start Date
September 1 2005
End Date
June 1 2008
Last Update
March 9 2012
Active Locations (3)
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1
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794
2
Great Lakes Cancer Institute Breslin Cancer Center
Lansing, Michigan, United States, 48910
3
The Methodist Hospital
Houston, Texas, United States, 77030