High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

Kidney Cancer Clinical Trial

Official title:

Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00080977
• Other study ID #: CDR0000357581
• Secondary ID: CMC-10-01-01AH
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: December 18, 2013
• Start date: June 1998

Study information

• Verified date: June 2005
• Source: National Cancer Institute (NCI)
• 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 renal cell carcinoma (kidney cancer) cells.

PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.

Description:

OBJECTIVES:

• Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.

• Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.

• Determine the toxicity of this drug in these patients.

OUTLINE: This is a pilot study.

Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).

Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity.

Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Metastatic disease

• No pure papillary or sarcomatoid variants

• Measurable disease

• Failed prior subcutaneous OR intravenous (dose = 50,000 IU/kg/day) interleukin-2

• Documented disease progression

• No estimated hepatic replacement by tumor > 25% by CT scan or MRI

• No tumor involving the CNS or a major nerve

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 80-100%

Life expectancy

• More than 3 months

Hematopoietic

• Platelet count = 80,000/mm^3

• No sites of ongoing bleeding

Hepatic

• See Disease Characteristics

• Bilirubin = 1.4 mg/dL

• AST and ALT = 3 times normal

• PT or PTT INR = 1.2

• Hepatitis B surface antigen negative

• Hepatitis C virus negative

• No coagulation disorders

Renal

• Creatinine = 1.6 mg/dL

Cardiovascular

• No ongoing ischemia*

• No cardiac dysfunction*

• No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients = 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram

Pulmonary

• FEV_1 = 65% of predicted*

• Vital capacity = 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph

Other

• HIV negative

• No AIDS

• No systemic infections

• No other malignancy except carcinoma in situ

• No psychiatric illness that would preclude study participation or compliance

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• No concurrent steroids

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 28 days since other prior treatment for renal cell cancer

• No concurrent immunosuppressive agents

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	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Blumenthal Cancer Center at Carolinas Medical Center

Country where clinical trial is conducted

United States,