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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080704 |
RATIONALE: ABT-510 may stop the growth of renal cell (kidney) cancer by stopping blood flow to the tumor.
PURPOSE: Randomized phase II trial to study the effectiveness of ABT-510 in treating patients who have locally recurrent or metastatic renal cell cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: ABT-510 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A Phase II Randomized Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Advanced Renal Cell Carcinoma |
Study Start Date: | November 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open-label, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients are followed at 30 days and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) 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 confirmed renal cell cancer
Measurable disease
At least 1 unidimensionally measurable lesion
No know CNS metastasis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation therapy
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-5907 |
Principal Investigator: | Robert A. Figlin, MD, FACP | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000355120, UCLA-0308112, ABBOTT-M02-428 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00080704 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |