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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionOct 2007
  4. Study completionFeb 2008

Resources

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)
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

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.

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