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Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer

2014-08-27 03:54:24 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and the chemosensitizer suramin and to see how well they work in treating patients with metastatic renal cell (kidney) cancer.

Description

OBJECTIVES: Phase I

Primary

- Determine the dose of suramin and fluorouracil that would result in plasma concentrations of suramin between 10-50 μM in patients with metastatic renal cell cancer.

Secondary

- Determine the preliminary efficacy of this regimen in these patients.

- Determine the pharmacokinetics of low-dose suramin in these patients. Phase II

Primary

- Determine the objective response rate (complete response and partial response) in patients treated with this regimen.

Secondary

- Determine the time to tumor progression and progress rate at 3 and 6 months in patients treated with this regimen.

OUTLINE: This is a dose-escalation phase I study followed by a phase II study.

- Phase I: Patients receive suramin IV over 30 minutes and fluorouracil IV on days 1, 8, 15, 22, 29, and 36.

Cohorts of 3-6 patients receive escalating doses suramin and fluorouracil until the dose level allowing 10-50 μM of suramin into the patient's blood is determined without 2 or more of 6 patients experiencing dose-limiting toxicity.

- Phase II: Patients receive suramin and fluorouracil (at the dose level determined in phase I) as in phase I.

In both phases, courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Kidney Cancer

Intervention

fluorouracil, suramin

Location

Cleveland Clinic Taussig Cancer Center
Cleveland
Ohio
United States
44195

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:24-0400

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Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

The outer zone of the KIDNEY, beneath the capsule, consisting of KIDNEY GLOMERULUS; KIDNEY TUBULES, DISTAL; and KIDNEY TUBULES, PROXIMAL.

Long convoluted tubules in the nephrons. They collect filtrate from blood passing through the KIDNEY GLOMERULUS and process this filtrate into URINE. Each renal tubule consists of a BOWMAN CAPSULE; PROXIMAL KIDNEY TUBULE; LOOP OF HENLE; DISTAL KIDNEY TUBULE; and KIDNEY COLLECTING DUCT leading to the central cavity of the kidney (KIDNEY PELVIS) that connects to the URETER.

Stones in the KIDNEY, usually formed in the urine-collecting area of the kidney (KIDNEY PELVIS). Their sizes vary and most contains CALCIUM OXALATE.

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