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Completed

NCT Number: NCT00265135

A Study of 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.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CNTO 328

Drug

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.

Primary outcomes

  1. 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

  2. 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.

  3. Serum Concentration of CNTO 328 (Parts 1, 2, and 3)

    Time frame: Pre dose, up to 6 weeks after the last dose

  4. Number of Participants With Adverse Events (Parts 1, 2, and 3)

    Time frame: Up to 6 weeks after the last dose

  5. 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)

  6. 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)

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Registry information

Official study title

A Phase I/II Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) in Subjects With Metastatic Renal Cell Carcinoma

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Dec 14, 2005
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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