NCT00095186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 10, 2008

Status Verified

April 1, 2008

First QC Date

November 1, 2004

Last Update Submit

April 8, 2008

Conditions

Carcinoma, Renal Cell

Keywords

CancerMetastaticKidneyRefractiveLactoferrinOral

Outcome Measures

Primary Outcomes (2)

  • Best Overall Response rate using RECIST criteria

  • 14-WeekProgression-Free Survival (PFS) rate

Secondary Outcomes (4)

  • 4 month and 8 month Progression-Free Survival (PFS) rates

  • Median progression-free survival

  • Median Overall Survival (OS) and 1-year OS rate

  • Toxicity

Interventions

Recombinant Human LactoferrinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California

Los Angeles, California, 90095, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 66037, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

VA Medical Center/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellNeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ernest W. Yankee, Ph.D.

    Agennix, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 2004

First Posted

November 2, 2004

Study Start

September 1, 2004

Study Completion

March 1, 2007

Last Updated

April 10, 2008

Record last verified: 2008-04

Locations

US(6)