- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00045279
PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- 01-143
- CDR0000256464 (Registry Identifier: PDQ (Physician Data Query))
- NCI-G-02-2102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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