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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006003 |
RATIONALE: SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: semaxanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma |
Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 18-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma with documented metastatic disease
Measurable disease
Known history of CNS metastasis who have had treatment, are neurologically stable, and do not require intravenous antibiotics or anticonvulsants eligible provided oral steroids are not required and brain scan (CT or MRI) shows absence of active or residual disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
Division of Hematology/Oncology | |
Park Ridge, Illinois, United States, 60068 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Cancer Care Specialists of Central Illinois, S.C. | |
Decatur, Illinois, United States, 62526 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 | |
Michiana Hematology/Oncology P.C. | |
South Bend, Indiana, United States, 46601 |
Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
Study ID Numbers: | CDR0000068011, UCCRC-10395, NCI-48 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006003 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Nevus |
SU 5416 Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |