Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006864
• Other study ID #: CHIR1899
• Secondary ID: CWRU-CHIR-1899CH
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2000
• Last updated: January 8, 2014
• Start date: July 2000
• Est. completion date: July 2007

Study information

• Verified date: January 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Northwestern Connecticut Oncology-Hematology Associates	Torrington	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	Chiron Corporation, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,