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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00045279
First Posted: January 27, 2003
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center
  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 Intervention Phase
Kidney Cancer Biological: PEG-interferon alfa-2b Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: April 2002
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045279


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00045279     History of Changes
Other Study ID Numbers: 01-143
CDR0000256464 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-G-02-2102
First Submitted: September 6, 2002
First Posted: January 27, 2003
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Interferons
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs