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Carcinoma, Renal CellPhase 2NCT00095186

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

A Phase 2 study testing Recombinant Human Lactoferrin in people with Carcinoma, Renal Cell, run by Agennix at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Recombinant Human Lactoferrin
How many people
40 participants
Where
6 sitesUnited States
Study dates
Sep 2004to Mar 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • The University of Chicago Medical Center

    Chicago, Illinois, 66037

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • VA Medical Center/Baylor College of Medicine

    Houston, Texas, 77030

  • University of California

    Los Angeles, California, 90095

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Recombinant Human Lactoferrin
Keywords
Cancer, Metastatic, Kidney, Refractive, Lactoferrin, Oral
Medical subject headings
Carcinoma, Renal Cell, Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human LactoferrinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Overall Response rate using RECIST criteria

  2. 14-WeekProgression-Free Survival (PFS) rate

Secondary outcomes (4)

  1. 4 month and 8 month Progression-Free Survival (PFS) rates

  2. Median progression-free survival

  3. Median Overall Survival (OS) and 1-year OS rate

  4. Toxicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2004 (estimated)
  2. Study startSep 2004
  3. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00095186
Sponsor's protocol ID
LF-0209
Status last verified
Apr 2008
First submitted
1 Nov 2004
Last updated
10 Apr 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Human Lactoferrin in people with Carcinoma, Renal Cell, run by Agennix at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response rate using RECIST criteria. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00095186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.

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