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| Sponsor: | The Cleveland Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00083109 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: fluorouracil Drug: suramin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Trial Of Low Dose Suramin (CI-1003, NSC#34936) And 5-Fluorouracil In Patients With Metastatic Renal Cell Carcinoma (RCC) |
| Study Start Date: | March 2004 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES: Phase I
Primary
Secondary
Primary
Secondary
OUTLINE: This is a dose-escalation phase I study followed by a phase II study.
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell cancer
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Ronald M. Bukowski, MD | The Cleveland Clinic |
More Information
| Study ID Numbers: | CDR0000363559, CCF-6101, NCI-6036, CWRU-CASE-1804 |
| Study First Received: | May 14, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00083109 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent renal cell cancer stage IV renal cell cancer |
|
Antimetabolites Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Antiparasitic Agents Neoplasms by Site Urologic Diseases Kidney Neoplasms |
Therapeutic Uses Kidney Diseases Antinematodal Agents Neoplasms by Histologic Type Suramin Anthelmintics Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Fluorouracil Carcinoma, Renal Cell Adenocarcinoma Neoplasms, Glandular and Epithelial |