Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
18 Years
N/A
Both
Kidney Cancer
Trial Information
Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
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.
Inclusion Criteria
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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Cindy Connell, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospitals Seidman Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068335
NCT ID:
NCT00006864
Start Date:
July 2000
Completion Date:
Related Keywords:
- Kidney Cancer
- stage IV renal cell cancer
- recurrent renal cell cancer
- clear cell renal cell carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Northwestern Connecticut Oncology-Hematology Associates | Torrington, Connecticut 06790 |
