Interferon Alfa-2b |
Intron A |
Clinical Trial: PEG-Interferon alfa-2b in Treating Patients With Metastatic Kidney Cancer
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Stage IV Renal Cell Cancer | Drug: PEG-interferon alfa-2b Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: cytokine therapy Procedure: growth factor antagonist therapy Procedure: interferon therapy | Phase II |
MedlinePlus related topics: Cancer; Kidney Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of PEG-Interferon alfa-2b in Patients With Metastatic Renal Cell Carcinoma
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
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
Location Information
Robert J. Motzer, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2004
Last Updated: November 4, 2004
Record first received: September 6, 2002
ClinicalTrials.gov Identifier: NCT00045279
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Interferon Alfa-2b (Drug Digest)
- Intron A (Drug Digest)

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