Kidney Cancer Clinical Trial

Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

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)

Study is for people with:

Kidney Cancer

Phase:

Phase 4

Study ID:

NCT00006864

Recruitment Status:

Completed

Sponsor:

Case Comprehensive Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Northwestern Connecticut Oncology-Hematology Associates
Torrington Connecticut, 06790, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 4

Study ID:

NCT00006864

Recruitment Status:

Completed

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider