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Sponsors and Collaborators: |
University of Vermont National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00293501 |
RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well it works in treating patients with metastatic kidney cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: tinzaparin sodium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot, multicenter study.
Patients receive a treatment dose of tinzaparin sodium subcutaneously (SC) once daily for 14 days followed by a prophylactic dose of tinzaparin sodium SC once daily for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma of clear cell histology
Metastatic and unresectable disease that is clinically extending beyond the regional lymph nodes (histological confirmation not required)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No other concurrent anticoagulation therapy, including oral anticoagulants, thrombolytic agents, or any form of heparin
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, New Hampshire | |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, Vermont | |
Vermont Cancer Center at University of Vermont | |
Burlington, Vermont, United States, 05405-0110 |
Study Chair: | Deborah L. Ornstein, MD | Yale University |
Study ID Numbers: | CDR0000459794, VCC-0403, VCC-05-040 |
Study First Received: | February 16, 2006 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00293501 History of Changes |
Health Authority: | United States: Food and Drug Administration |
clear cell renal cell carcinoma stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Kidney Cancer Anticoagulants Heparin, Low-Molecular-Weight Fibrinolytic Agents Urogenital Neoplasms Cardiovascular Agents Urologic Neoplasms Recurrence Calcium heparin Carcinoma Body Weight |
Fibrin Modulating Agents Renal Cancer Urologic Diseases Kidney Neoplasms Tinzaparin Clear Cell Renal Cell Carcinoma Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Heparin Neoplasms, Glandular and Epithelial |
Anticoagulants Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Heparin, Low-Molecular-Weight Hematologic Agents Fibrinolytic Agents Urogenital Neoplasms Cardiovascular Agents Urologic Neoplasms Pharmacologic Actions Carcinoma |
Fibrin Modulating Agents Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Tinzaparin Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |