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

Sponsor

Agennix (Industry)

Overall Status

Completed

CT.gov ID

NCT00095186

Collaborator

(none)

Enrollment

Locations

29.9

Duration (Months)

6.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 one prior systemic therapy for RCC.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: Recombinant Human Lactoferrin	Phase 2

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 orally for two cycles each of 12 consecutive weeks followed by 2 weeks off. A maximum of two additional cycles may be given if an objective response is obtained or if the patient has stable disease and no increase in the size of the target tumor(s) relative to either the Screening CT or the most recent CT measurement, measured according to RECIST prior to the additional cycle(s). Response and progression-free survival will be evaluated for the first 20 patients enrolled. If no patient has an objective response and less than 10% of the patients are alive and progression-free at 14 weeks from the start of Study Drug, then the study will be terminated. If in either Cycle 3 or Cycle 4, more than three out of the first ten patients or more than six out of the first twenty patients entering the cycle experience a Grade 3 or 4 Study-Drug-related adverse event, no further patients will advance into Cycle 3 or Cycle 4.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Phase 2, Open Label Study of Safety and Efficacy of Oral Recombinant Human Lactoferrin (rhLF) Monotherapy in Patients With Advanced Renal Cell Carcinoma (RCC), Who Have Failed at Least One Regimen of Systemic Therapy for RCC

Study Start Date :

Sep 1, 2004

Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Best Overall Response rate using RECIST criteria []
14-WeekProgression-Free Survival (PFS) rate []

Secondary Outcome Measures

4 month and 8 month Progression-Free Survival (PFS) rates []
Median progression-free survival []
Median Overall Survival (OS) and 1-year OS rate []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	M.D. Anderson Cancer Center	Houston	Texas	United States	77030
6	VA Medical Center/Baylor College of Medicine	Houston	Texas	United States	77030