Carcinoma, Renal CellPhase 1/2NCT00265135
A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma
A Phase 1/2 study testing CNTO 328 in people with Carcinoma, Renal Cell, run by Centocor, Inc. at 14 sites in 4 countries.
Trial summary
The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream. 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?
- CNTO 328
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Aug 2003to Feb 2006
- Phase
- Phase 1/2
- 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
- Clinical diagnosis (histologically confirmed, preferably) of metastatic renal cell carcinoma with documented metastases beyond the level of the regional lymphatics (ie, any T, any N, M1 disease)
- Measurable or evaluable disease (Part 1); measurable disease (Part 2 and Part 3)
- Documented disease progression based on objective tumor assessment (Part 2 and Part 3), proven by tumor measurements on 2 computerized tomography scans within 6 months prior to enrollment
- Life expectancy greater than or equal to 6 months at screening
- Serum C-reactive protein (CRP): detectable ( 4 mg/L or more) according to the standard assay of the core laboratory (Part 1 and Part 2); serum CRP detectable to 30 mg/L or more (Part 3)
Who cannot join
- Received any investigational drug within 30 days, whichever is longer
- History of receiving murine or chimeric proteins or human/murine recombination products (such as BE8 and other anti-IL-6 monoclonal antibodies)
- Serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure
- Chronic infection, prior history of recurrent infection, or clinically important active infection
- Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or peripheral blood stem cell transplant
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
France5 sites
Study site
Caen
Study site
Lyon
Study site
Montpellier
Study site
Montpellier Cedex 5 N/A
Study site
Villejuif
United Kingdom4 sites
Study site
Birmingham
Study site
Leeds
Study site
Manchester
Study site
Plymouth
Netherlands3 sites
Study site
Groningen
Study site
Nijmegen
Study site
Rotterdam
About this study
Official title: A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma
The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.
Read the detailed description
This research study uses a type of drug called anti-IL-6 monoclonal antibody, also known as CNTO 328. CNTO 328 is a new experimental drug. This study is trying to better understand the safety, the tolerability (side effects), and the distribution of the drug in the blood stream. The effects of CNTO 328 in patients with renal cell carcinoma are currently unknown. However, recent data has shown that treatment with another anti-IL-6 monoclonal antibody reduces the symptoms of renal cell carcinoma.
The study is divided in 3 parts. Part 1 is the phase I portion of the study and evaluated the safety of CNTO 328 in subjects with metastatic renal cell carcinoma. Part 2 and 3 will evaluate efficacy and safety of the drug in this patient population.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- CNTO 328
- Keywords
- Renal cell carcinoma, CNTO 328, Infusions, Renal cell cancer
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 328Drug
Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (CNTO 328) | Experimental | In Part 1 of the study, 4 intravenous infusions (IV) [injection of a substance into a vein] of CNTO 328 will be administered to patients in 4 dose levels ranging from 1, 3, 6, and 12 mg/kg on days 1, 29, 43, and 57 to determine the maximum tolerated dose for Part 2 of the study. Receives: Drug: CNTO 328 |
| Part 2 (CNTO 328) | Experimental | In Part 2 of the study, 2 well tolerated dose levels of CNTO 328 from Part 1 of the study will be administered every 3 weeks as 4 IV infusions to patients. Receives: Drug: CNTO 328 |
| Part 3 (CNTO 328) | Experimental | In Part 3 of the study, CNTO 328 at a dose level of 6 mg/kg will be administered as IV infusion every 2 weeks for at least 6 doses. Receives: Drug: CNTO 328 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Dose-limiting Toxicity as a Measure of Safety (Parts 1 and 3)
Measured: Up to 6 weeks after the last dose
Number of Patients With Tumor Response (Parts 2 and 3)
Tumor response will be evaluated as sum of complete response (CR) and partial response (PR). CR is disappearance of all measurable and evaluable disease. No new lesions. No evidence of non evaluable disease. PR is 50% or more decrease from baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.
Measured: Up to Week 11
Serum Concentration of CNTO 328 (Parts 1, 2, and 3)
Measured: Pre dose, up to 6 weeks after the last dose
Number of Participants With Adverse Events (Parts 1, 2, and 3)
Measured: Up to 6 weeks after the last dose
Change From Baseline in C-reactive Protein (Part 1)
Measured: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Change From Baseline in Interleukin-6 levels (Part 1)
Measured: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Secondary outcomes (8)
Serum Antibodies to CNTO 328 (Parts 1, 2, and 3)
Serum levels of antibodies to CNTO 328 will be used to evaluate potential immunogenicity.
Measured: Up to 6 weeks after the last dose
Number of Patients With Clinical Benefit (Parts 1, 2, and 3)
Clinical benefit will include assessment of pain (measured using Brief Pain Inventory which includes 4 items assessing pain intensity (pain intensity subscales) and 7 items assessing how much pain has interfered with daily activities (pain interference subscales). The pain intensity score is assessed with 4 questions rated on 11-point numerical rating scale (NRS) ranging from "0 = no pain" to "10 = higher severity of pain". The pain interference score is assessed with 7 questions rated on 11-point numerical rating scale (NRS) ranging from "0 = does not interfere" to "10 = completely interferes". Higher scores indicate worsening), functional impairment (assessed using Karnofsky performance status which quantifies patient's well-being and activities of daily life), weight change (assessed by change in body weight).
Measured: Up to 6 weeks after the last dose
Time to disease progression (Parts 2 and 3)
Disease progression is defines as greater than or equal to 25% increase in the sum of products of measurable lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion which had disappeared, or appearance of any new lesion, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Measured: Up to 6 weeks after the last dose
Duration of Tumor Response (Parts 2 and 3)
Duration of tumor response is defined as sum of complete response which is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of nonevaluable disease and partial response which is 50% or more decrease from baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.
Measured: Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose
Number of Patients With an Overall Tumor Response (Parts 2 and 3)
Overall tumor response is defined as sum of overall CR which is 2 or more objective responses of CR (complete disappearance of all measurable and evaluable disease.) documented for a minimum of 4 weeks apart, overall PR which is 2 or more objective responses of PR (50% or more decrease from baseline in the sum of products of perpendicular diameters of all measurable lesions.) or better documented for a minimum of 4 weeks apart, and overall stable disease which is at least 1 objective response of SD (radiologic assessments have been evaluated and does not qualify for CR, PR, or progressive disease) at least 3 weeks after baseline.
Measured: Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose
Change From Baseline in Quality of Life Measured Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue questionnaire (Parts 1, 2, and 3)
FACIT - Fatigue scale is a questionnaire to assess fatigue. It is a 13-item questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responded to each area are scored from 0 (not at all) to 4 (very much). Higher scores indicate worsening.
Measured: Within 2 weeks before dose, prior to first dose, Days 29, 43, 57, and 71, and 6 weeks after the last dose
Change From Baseline in C-reactive Protein (Parts 2 and 3)
Measured: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Change From Baseline in Interleukin-6 levels (Parts 2 and 3)
Measured: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startAug 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265135
- Sponsor's protocol ID
- CR005278
- Other IDs
- C0328T01
- Status last verified
- Jul 2014
- First submitted
- 13 Dec 2005
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00265135
- Acronym / sponsor ID
- CR005278
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Renal cell carcinoma, CNTO 328, Infusions, Renal cell cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the safety, tolerability and distribution of CNTO 328 in the bloodstream.
Detailed description
This research study uses a type of drug called anti-IL-6 monoclonal antibody, also known as CNTO 328. CNTO 328 is a new experimental drug. This study is trying to better understand the safety, the tolerability (side effects), and the distribution of the drug in the blood stream. The effects of CNTO 328 in patients with renal cell carcinoma are currently unknown. However, recent data has shown that treatment with another anti-IL-6 monoclonal antibody reduces the symptoms of renal cell carcinoma.
The study is divided in 3 parts. Part 1 is the phase I portion of the study and evaluated the safety of CNTO 328 in subjects with metastatic renal cell carcinoma. Part 2 and 3 will evaluate efficacy and safety of the drug in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 (CNTO 328) | Experimental | Drug: CNTO 328In Part 1 of the study, 4 intravenous infusions (IV) [injection of a substance into a vein] of CNTO 328 will be administered to patients in 4 dose levels ranging from 1, 3, 6, and 12 mg/kg on days 1, 29, 43, and 57 to determine the maximum tolerated dose for Part 2 of the study. |
| Part 2 (CNTO 328) | Experimental | Drug: CNTO 328In Part 2 of the study, 2 well tolerated dose levels of CNTO 328 from Part 1 of the study will be administered every 3 weeks as 4 IV infusions to patients. |
| Part 3 (CNTO 328) | Experimental | Drug: CNTO 328In Part 3 of the study, CNTO 328 at a dose level of 6 mg/kg will be administered as IV infusion every 2 weeks for at least 6 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis (histologically confirmed, preferably) of metastatic renal cell carcinoma with documented metastases beyond the level of the regional lymphatics (ie, any T, any N, M1 disease)
- Measurable or evaluable disease (Part 1); measurable disease (Part 2 and Part 3)
- Documented disease progression based on objective tumor assessment (Part 2 and Part 3), proven by tumor measurements on 2 computerized tomography scans within 6 months prior to enrollment
- Life expectancy greater than or equal to 6 months at screening
- Serum C-reactive protein (CRP): detectable ( 4 mg/L or more) according to the standard assay of the core laboratory (Part 1 and Part 2); serum CRP detectable to 30 mg/L or more (Part 3)
Key exclusion criteria (5 listed)
- Received any investigational drug within 30 days, whichever is longer
- History of receiving murine or chimeric proteins or human/murine recombination products (such as BE8 and other anti-IL-6 monoclonal antibodies)
- Serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure
- Chronic infection, prior history of recurrent infection, or clinically important active infection
- Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or peripheral blood stem cell transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CNTO 328Patients will receive CNTO 328 at dose levels ranging from 1, 3, 6, and 12 mg/kg in Part 1 of the study to determine the maximum tolerated dose for Part 2 of the study. Patients will receive 2 well tolerated dose levels of CNTO 328 from Part 1 of the study every 3 weeks in Part 2 of the study. Patients will receive 6 mg/kg of CNTO 328 every 2 weeks in Part 3 of the study. | Drug | Part 1 (CNTO 328), Part 2 (CNTO 328), Part 3 (CNTO 328) |
Primary outcome
Number of Patients With Dose-limiting Toxicity as a Measure of Safety (Parts 1 and 3)
Time frame: Up to 6 weeks after the last dose
Number of Patients With Tumor Response (Parts 2 and 3)
Time frame: Up to Week 11
Tumor response will be evaluated as sum of complete response (CR) and partial response (PR). CR is disappearance of all measurable and evaluable disease. No new lesions. No evidence of non evaluable disease. PR is 50% or more decrease from baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.
Serum Concentration of CNTO 328 (Parts 1, 2, and 3)
Time frame: Pre dose, up to 6 weeks after the last dose
Number of Participants With Adverse Events (Parts 1, 2, and 3)
Time frame: Up to 6 weeks after the last dose
Change From Baseline in C-reactive Protein (Part 1)
Time frame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Change From Baseline in Interleukin-6 levels (Part 1)
Time frame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
8 secondary outcomes
Serum Antibodies to CNTO 328 (Parts 1, 2, and 3)
Time frame: Up to 6 weeks after the last dose
Number of Patients With Clinical Benefit (Parts 1, 2, and 3)
Time frame: Up to 6 weeks after the last dose
Time to disease progression (Parts 2 and 3)
Time frame: Up to 6 weeks after the last dose
Duration of Tumor Response (Parts 2 and 3)
Time frame: Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose
Number of Patients With an Overall Tumor Response (Parts 2 and 3)
Time frame: Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose
Change From Baseline in Quality of Life Measured Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue questionnaire (Parts 1, 2, and 3)
Time frame: Within 2 weeks before dose, prior to first dose, Days 29, 43, 57, and 71, and 6 weeks after the last dose
Change From Baseline in C-reactive Protein (Parts 2 and 3)
Time frame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Change From Baseline in Interleukin-6 levels (Parts 2 and 3)
Time frame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- A Phase 1/2 Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects with Metastatic Renal Cell CarcinomaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CNTO 328 in people with Carcinoma, Renal Cell, run by Centocor, Inc. at 14 sites in 4 countries.
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 5 inclusion and 5 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 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, United Kingdom, Netherlands, Czechia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of Patients With Dose-limiting Toxicity as a Measure of Safety (Parts 1 and 3) (time frame: Up to 6 weeks after the last dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2014.