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Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern Connecticut Oncology-Hematology Associates
  • Ireland Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 6, 2000
Last Updated
January 8, 2014
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), Chiron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00006864
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), Chiron Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Connell, MD, PhD
Organizational Affiliation
University Hospitals Seidman Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern Connecticut Oncology-Hematology Associates
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

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