Kidney CancerPhase 2NCT00311545
S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase 2 study testing CNTO 328 in people with Kidney Cancer, run by SWOG Cancer Research Network.
Trial summary
RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic or unresectable primary renal cell carcinoma
- Measurable disease
- Soft tissue disease within a prior radiation field may be considered measurable disease provided all of the following are true:
- Patient also has measurable disease outside of the irradiated field
- Disease within the irradiated field has progressed since prior radiotherapy
- Radiotherapy was completed more than 2 months ago
- Ineligible for high-dose interleukin-2
- No treated or untreated brain metastases
- No history of brain metastases
- Patients with clinical evidence of brain metastases must have brain CT scan or MRI negative for metastatic disease within 56 days prior to study entry
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine clearance ≥ 40 mL/min
- Bilirubin ≤ 3 times upper limit of normal (ULN)
- SGOT ≤ 3 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No more than 2 of the following:
- Zubrod PS 2
- Lactate dehydrogenase > 1.5 times ULN
- Hemoglobin < lower limit of normal
- Calcium > 10 mg/dL
- Absence of prior nephrectomy
- No uncontrolled intercurrent illness, including any of the following:
- Uncontrolled diabetes mellitus
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with study requirements
- No HIV positivity
- No other prior malignancy, excluding the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer for which the patient is currently in complete remission
- Any other cancer for which the patient has been disease free for 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 28 days since prior tumor resection and recovered
- No prior immunotherapy or chemotherapy regimens with interferon (IFN) and/or interleukin-2 (IL-2) or the combination of IFN/IL-2
- No prior cytotoxic chemotherapy for renal cell cancer
- No prior murine or chimeric proteins or human/murine recombination products (i.e., other chimeric monoclonal antibodies)
- No concurrent radiotherapy or systemic therapy for renal cell cancer
About this study
Official title: A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer
RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess the probability of response (confirmed complete and partial responses) in patients with unresectable or metastatic renal cell cancer treated with CNTO 328.
Secondary
- Assess the 6-month progression-free survival probability and median overall survival in these patients.
- Evaluate the qualitative and quantitative toxicities of this treatment.
- Investigate, in a preliminary manner, the association of tumor response with potential markers of anti-interleukin-6 activity.
OUTLINE: This is a multicenter study.
Patients receive CNTO 328 IV over 2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete or partial response after 6 courses of therapy may receive an additional 6 courses.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- CNTO 328
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTO 328Biological
Also called Siltuximab
Anti-IL-6 chimeric monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| CNTO 328 | Experimental | CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks) Receives: Biological: CNTO 328 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
Why it stopped: withdrawal of support for drug supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacek K. Pinski, MD, Study chair, University of Southern CaliforniaPhilip C. Mack, Ph.D., Study chair, UC Davis Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311545
- Sponsor's protocol ID
- CDR0000462096
- Other IDs
- S0351, U10CA032102
- Status last verified
- Feb 2013
- First submitted
- 5 Apr 2006
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00311545
- Acronym / sponsor ID
- CDR0000462096
- Conditions
- Kidney Cancer
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawal of support for drug supply
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 6 Apr 2006 (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.
RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Assess the probability of response (confirmed complete and partial responses) in patients with unresectable or metastatic renal cell cancer treated with CNTO 328.
Secondary
- Assess the 6-month progression-free survival probability and median overall survival in these patients.
- Evaluate the qualitative and quantitative toxicities of this treatment.
- Investigate, in a preliminary manner, the association of tumor response with potential markers of anti-interleukin-6 activity.
OUTLINE: This is a multicenter study.
Patients receive CNTO 328 IV over 2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete or partial response after 6 courses of therapy may receive an additional 6 courses.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNTO 328 | Experimental | Biological: CNTO 328CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 328Also: SiltuximabAnti-IL-6 chimeric monoclonal antibody | Biological | CNTO 328 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
Jacek K. Pinski, MD study chair
University of Southern California
Philip C. Mack, Ph.D. study chair
UC Davis Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTO 328 in people with Kidney Cancer, run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
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 20 Feb 2013.