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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agennix
• Treatments: Lactoferrin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Sexually active male patients unwilling to practice contraception while participating on this study and up to 30 days after completion of treatment

• Unable to take liquid medication by mouth or feeding tube