Clinical trial NCT00006864: Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Official title: Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
recurrent renal cell cancer
clear cell renal cell carcinoma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Chiron Corporation
First posted: 2003-06-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrington
country: United States
facility: Northwestern Connecticut Oncology-Hematology Associates
state: Connecticut
city: Cleveland
country: United States
facility: Ireland Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Seidman Cancer Center
name: Cindy Connell, MD, PhD
role: STUDY_CHAIR
References: