Status:
COMPLETED
Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma
Lead Sponsor:
Agennix
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is an open label, multi-center Phase 2 study. Approximately 40 patients will be enrolled in a single study arm. RhLF, at a dose of 1.5 g \[1 vial\], twice a day (b.i.d.), will be administered ora...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00095186
Start Date
September 1 2004
End Date
March 1 2007
Last Update
April 10 2008
Active Locations (6)
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1
University of California
Los Angeles, California, United States, 90095
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
The University of Chicago Medical Center
Chicago, Illinois, United States, 66037
4
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195