Clinical trial NCT00265135: A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma
Official title: A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Renal cell carcinoma
CNTO 328
Infusions
Renal cell cancer
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Patients With Dose-limiting Toxicity as a Measure of Safety (Parts 1 and 3)
timeFrame: Up to 6 weeks after the last dose
measure: Number of Patients With Tumor Response (Parts 2 and 3)
timeFrame: Up to Week 11
measure: Serum Concentration of CNTO 328 (Parts 1, 2, and 3)
timeFrame: Pre dose, up to 6 weeks after the last dose
measure: Number of Participants With Adverse Events (Parts 1, 2, and 3)
timeFrame: Up to 6 weeks after the last dose
measure: Change From Baseline in C-reactive Protein (Part 1)
timeFrame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
measure: Change From Baseline in Interleukin-6 levels (Part 1)
timeFrame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Secondary outcomes:
measure: Serum Antibodies to CNTO 328 (Parts 1, 2, and 3)
timeFrame: Up to 6 weeks after the last dose
measure: Number of Patients With Clinical Benefit (Parts 1, 2, and 3)
timeFrame: Up to 6 weeks after the last dose
measure: Time to disease progression (Parts 2 and 3)
timeFrame: Up to 6 weeks after the last dose
measure: Duration of Tumor Response (Parts 2 and 3)
timeFrame: Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose
measure: Number of Patients With an Overall Tumor Response (Parts 2 and 3)
timeFrame: Screening (3 weeks prior to first dose), Week 7, Week 11, and 6 weeks after the last dose
measure: Change From Baseline in Quality of Life Measured Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue questionnaire (Parts 1, 2, and 3)
timeFrame: Within 2 weeks before dose, prior to first dose, Days 29, 43, 57, and 71, and 6 weeks after the last dose
measure: Change From Baseline in C-reactive Protein (Parts 2 and 3)
timeFrame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
measure: Change From Baseline in Interleukin-6 levels (Parts 2 and 3)
timeFrame: Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Hradec Nad Svitavou
country: Czech Republic
city: Caen
country: France
city: Lyon Cedex 08
country: France
city: Montpellier Cedex 5 N/A
country: France
city: Montpellier
country: France
city: Villejuif N/A
country: France
city: Groningen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Birmingham
country: United Kingdom
city: Leeds
country: United Kingdom
city: Manchester
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: