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Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

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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 CenterCleveland, Ohio  44106-5065
Northwestern Connecticut Oncology-Hematology AssociatesTorrington, Connecticut  06790