Kidney CancerPhase 4NCT00006864
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
A Phase 4 study testing aldesleukin in people with Kidney Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer. 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?
- aldesleukin
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jul 2000to Jul 2007
- Phase
- Phase 4
- 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 proven metastatic renal cell carcinoma
- Clear cell
- Papillary
- Sarcomatoid
- Mixed
- Measurable or evaluable disease
- Evidence of disease following surgical resection of metastases
- No CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 10 g/dL
- WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 1.8 mg/dL
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception (barrier plus 1 other method)
- Thyroid-stimulating hormone normal
- No known hypersensitivity or allergy to components of recombinant human interleukin-2
- No known autoimmune disease (e.g., Crohn's disease)
- No other concurrent medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior recombinant human interleukin-2
- No concurrent interferon alfa
Chemotherapy:
- No concurrent cytoxic chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy
- No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed)
- No concurrent systemic corticosteroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to index lesion
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Prior surgery for renal cell carcinoma allowed
Other:
- No prior systemic therapy for renal cell carcinoma
- At least 4 weeks since prior investigational drugs
- No other concurrent investigational drugs or participation in another clinical study
- No concurrent iodinated radiocontrast dye
- No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Northwestern Connecticut Oncology-Hematology Associates
Torrington, Connecticut, 06790
About this study
Official title: Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
- Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2.
- Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen.
- Determine the incidence of adverse events in these patients.
OUTLINE: This is a multicenter study.
Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- aldesleukin
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
- 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.
aldesleukinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2003 (estimated)
- Study startJul 2000
- Primary completionJul 2007
- Study completionJul 2007
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 Case Comprehensive Cancer CenterThe 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 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Chiron Corporation
- Responsible party
- Sponsor
- Investigators
- Cindy Connell, MD, PhD, Study chair, University Hospitals Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006864
- Sponsor's protocol ID
- CHIR1899
- Other IDs
- CWRU-CHIR-1899, CHIR-MA-99-01, CWRU-010002, NCI-G00-1875
- Status last verified
- Jan 2014
- First submitted
- 6 Dec 2000
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
- ClinicalTrials.gov ID
- NCT00006864
- Acronym / sponsor ID
- CHIR1899
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Chiron Corporation
- Study start
- Jul 2000
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 2 Jun 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: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.
Detailed description
OBJECTIVES:
- Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2.
- Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen.
- Determine the incidence of adverse events in these patients.
OUTLINE: This is a multicenter study.
Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| aldesleukin | 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 9 Jan 2014.
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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.
Cindy Connell, MD, PhD study chair
University Hospitals Seidman Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aldesleukin in people with Kidney Cancer, run by Case Comprehensive Cancer Center at 2 sites 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 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Jan 2014.