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PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

2014-08-27 03:54:05 | BioPortfolio

Summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

Description

OBJECTIVES:

Primary

- Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.

Secondary

- Determine duration of response in patients treated with this regimen.

- Determine the tolerance to and toxicity of this regimen in these patients.

- Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

PEG-interferon alfa-2b, sargramostim, thalidomide

Location

Hollings Cancer Center at Medical University of South Carolina
Charleston
South Carolina
United States
29425

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:05-0400

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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.

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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.

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

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).

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