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

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Cancer
• Intervention / Treatment: Biological: aldesleukin

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28232-2861
      • Blumenthal Cancer Center at Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Blumenthal Cancer Center at Carolinas Medical Center
• Investigators: Study Chair: Richard L. White, MD, Blumenthal Cancer Center at Carolinas Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 1998

Study Registration Dates

• First Submitted: April 7, 2004
• First Submitted That Met QC Criteria: April 7, 2004
• First Posted (Estimate): April 8, 2004

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: June 1, 2005

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; recurrent renal cell cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Aldesleukin
• Other Study ID Numbers: CDR0000357581; CMC-10-01-01AH