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Interferon Alfa in Treating Patients With Advanced Kidney Cancer

2014-08-27 03:58:39 | BioPortfolio

Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa in treating patients with advanced kidney cancer.

Description

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of pegylated-interferon alfa-2a in patients with advanced or metastatic renal cell carcinoma. II. Evaluate the safety profile of the MTD in this patient population. III. Determine the objective response rate, time to response, duration of response, time to progression, and survival rate in this patient population.

OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive pegylated-interferon alfa-2a (PEG-IFN) subcutaneously once a week for 24 weeks. Dose escalation of PEG-IFN continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. After the MTD of PEG-IFN is determined, additional patients are treated at this dose level. These patients may continue treatment after the first 24 weeks for up to 1 year, in the absence of disease progression. Patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 46-58 patients will be accrued for this study within 9 months.

Study Design

Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

pegylated interferon alfa

Location

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles
California
United States
90095-1781

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:39-0400

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Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.

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