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

Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00045279
Enrollment
Unknown
Registered
2003-01-27
Start date
2002-04-30
Completion date
2005-09-30
Last updated
2013-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Brief summary

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.

Detailed 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.

Interventions

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026