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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Cancer

Intervention: PEG-interferon alfa-2b (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Robert J. Motzer, MD, Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

Official title: Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma

Study design: Masking: Open Label, Primary Purpose: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

- 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

Locations and Contacts

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

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

Starting date: April 2002
Last updated: June 4, 2013

Page last updated: August 20, 2015

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