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Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

2014-08-27 03:55:48 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.

Description

OBJECTIVES:

- Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer.

- Determine the safety and tolerability of this regimen in these patients.

- Determine, preliminarily, any antitumor activity of this regimen in these patients.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive interferon alfa (IFN-A) subcutaneously 3 times a week. Beginning on week 2, patients also receive CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at that dose level.

Patients are followed at 30 days.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

recombinant interferon alfa, temsirolimus

Location

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

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:48-0400

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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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