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

April 8, 2008 updated by: Agennix

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 66037
        • The University of Chicago Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • VA Medical Center/Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Best Overall Response rate using RECIST criteria
14-WeekProgression-Free Survival (PFS) rate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agennix

Investigators

  • Study Chair: Ernest W. Yankee, Ph.D., Agennix, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

November 1, 2004

First Submitted That Met QC Criteria

November 1, 2004

First Posted (Estimate)

November 2, 2004

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 8, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LF-0209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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