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

NCT00329368 | Completed Phase 1

• 1 other identifier: EC-FI-003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Cancer; Vaccine; Phase I; FolateImmune; Recurrent; Refractory; Experimental

Outcome Measures

Primary Outcomes (3)

• Safety

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

• Tolerability

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

• Anti-tumor Activity

  From initial dose of study therapy to disease progression

Interventions

EC90 (KLH-FITC) BIOLOGICAL

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.

Also known as: Keyhole limpet hemocyanin fluorescein

GPI-0100 BIOLOGICAL

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.

Also known as: Saponin-based adjuvant

EC17 (Folate-FITC) DRUG

0.3mg/kg administered subcutaneously 5 days per week (Monday through Friday) for 4 consecutive weeks followed by 2 observation weeks for each cycle.

Also known as: folate-fluorescein conjugate, folate-hapten conjugate

Interleukin-2 DRUG

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

Also known as: IL-2, Proleukin

Interferon-alpha DRUG

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.

Also known as: IFN-alpha, Intron-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Endocyte: lead

Study Sites (3)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Great Lakes Cancer Institute Breslin Cancer Center

Lansing, Michigan, 48910, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Recurrence

Interventions

fluorescein isothiocyanate-keyhole limpet hemocyanin; GPI0100; Interleukin-2; aldesleukin; Interferon-alpha; Introns

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Interferon Type I; Interferons; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• Richard A Messmann, MD, MHS, BSc

  Endocyte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: September 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: June 1, 2008
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

US (3)