- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006864
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
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.
Study Overview
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 Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Connecticut
-
Torrington, Connecticut, United States, 06790
- Northwestern Connecticut Oncology-Hematology Associates
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Cindy Connell, MD, PhD, University Hospitals Seidman Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Aldesleukin
Other Study ID Numbers
- CHIR1899
- CWRU-CHIR-1899
- CHIR-MA-99-01
- CWRU-010002
- NCI-G00-1875
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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