PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Biological: PEG-interferon alfa-2b

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00045279

CDR0000256464 (Registry Identifier)

01-143

NCI-G-02-2102

Details and patient eligibility

About

RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.

Full description

OBJECTIVES:

• Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma.
• Determine the time to disease progression in patients treated with this drug.
• Determine the safety of this drug in these patients.
• Determine the quality of life of patients treated with this drug.
• Determine the effect of this drug on biological surrogates of antitumor activity (basic fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum levels) in these patients.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

  • Metastatic disease
  • No prior therapy for advanced disease

• Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076

• Bidimensionally measurable disease

• No brain metastases unless completely resected and without evidence of recurrence for at least six months

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm3
• Platelet count at least 100,000/mm3

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases)
• Hepatitis B surface antigen negative
• Hepatitis C negative

Renal

• Creatinine no greater than 2 mg/dL

Cardiovascular

• No severe cardiac disease
• No New York Heart Association class III or IV cardiac disease
• No myocardial infarction within the past 12 months
• No ventricular tachyarrhythmias requiring ongoing treatment
• No unstable angina

Pulmonary

• No severe asthma requiring chronic systemic steroids

Other

• HIV negative

• Negative pregnancy test

• Fertile patients must use effective contraception

• No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer

  • Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible

• No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization

• No prior or active autoimmune disease

• Medically controlled diabetes or thyroid dysfunction allowed

• No clinically significant acute viral or bacterial infection that requires specific therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interleukin-2
• No prior interferon alfa
• No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise
• No concurrent tumor vaccines
• No concurrent monoclonal antibodies
• No concurrent bone marrow/stem cell transplantation

Chemotherapy

• No concurrent cytotoxic agents

Endocrine therapy

• No concurrent high-dose systemic steroids
• Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed
• No concurrent hormonal therapy (including megestrol)
• Concurrent hormone replacement therapy or oral contraceptives allowed

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 4 weeks since prior major surgery
• Concurrent nephrectomy allowed

Other

• At least 14 days since prior anti-infectious therapy
• No other concurrent investigational drugs