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


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Interferon Alfa-2b

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

This study is no longer recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

OBJECTIVES:

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

Endocrine therapy

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


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Robert J. Motzer, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000256464; MSKCC-01143; NCI-G-02-2102
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



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November 29, 2009



Page Updated: June 1, 2005
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