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

This study has been completed.
Sponsor:
Information provided by:
Agennix
ClinicalTrials.gov Identifier:
NCT00095186
First received: November 1, 2004
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Drug: Recombinant Human Lactoferrin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Agennix:

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

Estimated Enrollment: 40
Study Start Date: September 2004
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095186

Locations
United States, California
University of California
Los Angeles, California, United States, 90095
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 66037
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Texas
VA Medical Center/Baylor College of Medicine
Houston, Texas, United States, 77030
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Agennix
Investigators
Study Chair: Ernest W. Yankee, Ph.D. Agennix, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00095186     History of Changes
Obsolete Identifiers: NCT00099034
Other Study ID Numbers: LF-0209
Study First Received: November 1, 2004
Last Updated: April 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Agennix:
Cancer
Metastatic
Kidney
Refractive
Lactoferrin
Oral

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014