- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00265135
A Study of CNTO 328 in Subjects With Metastatic Renal Cell Carcinoma
A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Brno, Czech Republic
-
Hradec Nad Svitavou, Czech Republic
-
-
-
-
-
Caen, France
-
Lyon Cedex 08, France
-
Montpellier, France
-
Montpellier Cedex 5 N/A, France
-
Villejuif N/A, France
-
-
-
-
-
Groningen, Netherlands
-
Nijmegen, Netherlands
-
Rotterdam, Netherlands
-
-
-
-
-
Birmingham, United Kingdom
-
Leeds, United Kingdom
-
Manchester, United Kingdom
-
Plymouth, United Kingdom
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Part 1 (CNTO 328)
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.
|
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.
|
EXPERIMENTAL: Part 2 (CNTO 328)
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.
|
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.
|
EXPERIMENTAL: Part 3 (CNTO 328)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Up to Week 11
|
Serum Concentration of CNTO 328 (Parts 1, 2, and 3)
Time Frame: Pre dose, up to 6 weeks after the last dose
|
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
|
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)
|
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)
|
Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Antibodies to CNTO 328 (Parts 1, 2, and 3)
Time Frame: Up to 6 weeks after the last dose
|
Serum levels of antibodies to CNTO 328 will be used to evaluate potential immunogenicity.
|
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
|
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).
|
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
|
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).
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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)
|
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)
|
Within 2 weeks before first dose, pre dose, post dose (6 weeks after the last dose)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005278
- C0328T01 (OTHER: Centocor)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Renal Cell
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
-
Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell CarcinomaUnited States, Taiwan, Australia
-
Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
-
Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
-
Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
-
AmgenCompletedRenal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | Clear Cell Renal Carcinoma | Renal Cell AdenocarcinomaFrance, United States, Germany
Clinical Trials on CNTO 328
-
Centocor, Inc.CompletedLymphoma, Non-Hodgkin | Multiple Myeloma | Giant Lymph Node HyperplasiaUnited States
-
Southwest Oncology GroupNational Cancer Institute (NCI)Withdrawn
-
Centocor, Inc.Completed
-
Northwestern UniversityNational Cancer Institute (NCI)WithdrawnPrimary Myelofibrosis | Polycythemia Vera | Myelofibrosis | Thrombocytopenia
-
Southwest Oncology GroupNational Cancer Institute (NCI)Completed
-
Janssen Research & Development, LLCCompletedMulticentric Castleman's DiseaseUnited States, Canada, France, United Kingdom, China, Germany, Taiwan, Spain, Belgium, Israel, India, Korea, Republic of, Netherlands, Singapore, Brazil, Russian Federation, New Zealand, Hungary, Norway, Australia, Egypt, Hong Kong, Malaysi...
-
Centocor, Inc.CompletedProstatic NeoplasmsUnited States
-
Emory UniversityNational Cancer Institute (NCI); Novartis; National Institutes of Health (NIH); EUSA Pharma, Inc...CompletedStage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic AdenocarcinomaUnited States
-
Centocor, Inc.CompletedHead and Neck Neoplasms | Lung Neoplasms | Colorectal Neoplasms | Pancreatic Neoplasms | Ovarian NeoplasmsUnited States, France, United Kingdom, Spain, Belgium
-
Timothy VoorheesRecruitingNon-Hodgkin LymphomaUnited States