Kidney CancerPhase 2NCT00057889
Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer
A Phase 2 study testing ipilimumab in people with Kidney Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- ipilimumab
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Feb 2008
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV clear cell renal carcinoma
- At least 1 site of measurable disease
- Meeting criteria for 1 of the following:
- Disease progression after prior interleukin-2 (IL-2)
- Ineligible for standard high-dose IV IL-2 due to comorbid medical conditions
- Minimal disease (lesions ≤ 3 cm that do not pose risk to organ function) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2
- Indolent disease (defined as an increase in tumor size of < 50% within the past 6 months) such that participation in this study is not likely to compromise the patient's opportunity to receive future high-dose IL-2
- No true papillary, medullary, chromophobe, collecting duct, or oncocytic renal cancer
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 3 months
Hematopoietic
- WBC ≥ 2,500/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Hematocrit ≥ 30%
Hepatic
- AST ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ ULN (< 3.0 mg/dL for patients with Gilbert's syndrome)
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Creatinine < 2.0 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No other malignancy except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for at least 5 years
- No autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
- No active uncontrolled infection
- No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
- At least 3 weeks since prior immunotherapy for renal cancer
Chemotherapy
- At least 3 weeks since prior chemotherapy for renal cancer
- No concurrent chemotherapy
Endocrine therapy
- At least 3 weeks since prior hormonal therapy for renal cancer
- More than 4 weeks since prior corticosteroids
- No concurrent systemic or topical corticosteroids
Radiotherapy
- At least 3 weeks since prior radiotherapy for renal cancer
Surgery
- Not specified
Other
- Recovered from prior therapy
- At least 3 weeks since other prior therapy for renal cancer
- No concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.
Read the detailed description
OBJECTIVES:
- Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2.
- Determine the impact of this drug on T-cell number and phenotype in these patients.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response may receive additional courses of therapy.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually until disease progression.
PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4 years.
- Conditions
- Kidney Cancer
- Being tested
- ipilimumab
- Keywords
- clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent 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.
ipilimumabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startFeb 2003
- Primary completionOct 2007
- Study completionFeb 2008
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.
- 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- James C. Yang, MD, Study chair, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057889
- Sponsor's protocol ID
- 030094
- Other IDs
- 03-C-0094, CDR0000285624
- Status last verified
- Mar 2012
- First submitted
- 7 Apr 2003
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer
- ClinicalTrials.gov ID
- NCT00057889
- Acronym / sponsor ID
- 030094
- Conditions
- Kidney Cancer
- Keywords
- clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 9 Apr 2003 (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 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer (kidney cancer) that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2.
Detailed description
OBJECTIVES:
- Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2.
- Determine the impact of this drug on T-cell number and phenotype in these patients.
OUTLINE: This is an open-label study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with an ongoing partial response may receive additional courses of therapy.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually until disease progression.
PROJECTED ACCRUAL: A total of 21-103 patients will be accrued for this study within 2-4 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| ipilimumab | Biological | – |
Primary outcome
Not reported in the source record.
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 15 Mar 2012.
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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.
James C. Yang, MD study chair
NCI - Surgery Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ipilimumab in people with Kidney Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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 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.
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 15 Mar 2012.