Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

The purpose of this study is to determine if orally-administered recombinant human lactoferrin is effective in the treatment of advanced renal cell carcinoma (RCC) in patients who have failed at least one prior systemic therapy for RCC.

Key facts

Study ID

NCT00095186

Run by

Agennix

People needed

40

Starts

2004-09-01

Expected to finish

2007-03-01

Last updated by the study team

2008-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years
• Histologically confirmed, advanced or metastatic RCC with predominantly clear cell histology that is unresectable or medically inoperable.
• Experienced and failed at least one regimen of systemic therapy for RCC with CT documentation of disease progression.
• A previous CT (4 weeks or more prior to the Screening CT) showing progression of the target tumor(s) compared to a prior CT no more than 9 months previously
• At least one target tumor lesion is measurable at Screening with CT scan, according to RECIST, and not previously irradiated
• Karnofsky performance status of ≥70 (ECOG <2)
• Able to understand and sign an informed consent

You may not qualify if…

• Significant sarcomatoid, spindle cell, or nuclear grade 4 histology
• Significant non-clear cell RCC (for example, papillary, chromophobe, collecting duct, granular, or unclassified RCC)
• Total bilirubin >1.5 mg/dL
• Serum creatinine >2.0 mg/dL
• Hemoglobin <10.0 g/dL
• Absolute neutrophil count <2000/mm3
• Lymphocytes <800/mm3
• Platelet count <100,000/mm3
• AST (SGOT) or ALT (SGPT) ≥2.5 x institutional upper limit of normal
• Serum calcium >11.5 mg/dl
• International Normalized Ratio of Prothrombin Time (INR) >1.2
• FEV1 <60% predicted or FVC <60% predicted by spirometry (both are to be measured)
• Existing or history of brain metastases
• History of allergic reactions to compounds of similar chemical or biologic composition to the Study Agent rhLF
• Active ischemic heart disease, symptomatic congestive heart failure
• Serious active infection
• Psychiatric illness/social situations that would limit compliance with study requirements
• Autoimmune diseases (e.g., systemic lupus erythematosus, multiple sclerosis or ankylosing spondylitis)
• Other malignancies, except non-melanoma skin cancer, within 5 years of study entry
• Radiotherapy within 4 weeks prior to study treatment start
• Corticosteroid therapy within 4 weeks prior to treatment start, with the exception of inhaled or topical steroids
• Chemotherapy/Immunotherapy (e.g., IL-2, INFα, tumor vaccine) within 4 weeks prior to study treatment start
• Known HIV positive
• Receipt of any investigational medication within 30 days prior to participation in the study
• Pregnant or lactating patients, or fertile female patients with a positive pregnancy test (serum β-human chorionic gonadotropin [β-HCG] at Screening and on Day 1 prior to the first dose), or fertile female patients unwilling to use adequate contraception prior to study entry, during treatment and 30 days after completion of treatment

Where it is running

• University of California — Los Angeles, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• VA Medical Center/Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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