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PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: September 6, 2002   Last Updated: February 6, 2009   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045279
  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 II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Study Start Date: April 2002
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000256464, MSKCC-01143, NCI-G-02-2102
Study First Received: September 6, 2002
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00045279     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Growth Inhibitors
Kidney Diseases
Angiogenesis Modulating Agents
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Carcinoma, Renal Cell
Peginterferon alfa-2b
Adenocarcinoma
Interferon Alfa-2a
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009