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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-interferon alfa-2b
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045279
Brief Title
PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Official Title
Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Motzer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18501079
Citation
Feldman DR, Kondagunta GV, Schwartz L, Patil S, Ishill N, DeLuca J, Russo P, Motzer RJ. Phase II trial of pegylated interferon-alpha 2b in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2008 Mar;6(1):25-30. doi: 10.3816/cgc.2008.n.004.
Results Reference
result
PubMed Identifier
12419754
Citation
Motzer RJ, Rakhit A, Thompson J, Gurney H, Selby P, Figlin R, Negrier S, Ernst S, Siebels M, Ginsberg M, Rittweger K, Hooftman L. Phase II trial of branched peginterferon-alpha 2a (40 kDa) for patients with advanced renal cell carcinoma. Ann Oncol. 2002 Nov;13(11):1799-805. doi: 10.1093/annonc/mdf288.
Results Reference
result

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

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