Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MSKCC-01143 NCI-G-02-2102, NCT00045279

Objectives

1. Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma.
2. Determine the time to disease progression in patients treated with this drug.
3. Determine the safety of this drug in these patients.
4. Determine the quality of life of patients treated with this drug.
5. 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.

Entry 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

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

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

Expected Enrollment

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

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.

Feldman DR, Kondagunta GV, Schwartz L, et al.: Phase II trial of pegylated interferon-alpha 2b in patients with advanced renal cell carcinoma. Clin Genitourin Cancer 6 (1): 25-30, 2008.[PUBMED Abstract]

Motzer RJ, Rakhit A, Thompson J, et al.: Phase II trial of branched peginterferon-alpha 2a (40 kDa) for patients with advanced renal cell carcinoma. Ann Oncol 13 (11): 1799-805, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Robert Motzer, MD, Protocol chair		Ph: 646-422-4312; 800-525-2225

Registry Information
Official Title		Phase II Trial of PEG-Intron in Patients with Advanced Renal Cell Carcinoma
Trial Start Date		2002-04-23
Registered in ClinicalTrials.gov		NCT00045279
Date Submitted to PDQ		2002-06-26
Information Last Verified		2004-10-18
NCI Grant/Contract Number		P30-CA08748

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