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

Blumenthal Cancer Center at Carolinas Medical Center

Status and phase: Unknown; Phase 2

Conditions: Kidney Cancer

Treatments: Biological: aldesleukin

Study type: Interventional

Funder types: Other

Identifiers

NCT00080977

CDR0000357581

CMC-10-01-01AH

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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