Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450255 |
RATIONALE: Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Intraocular Melanoma Melanoma (Skin) |
Biological: aflibercept Other: immunoenzyme technique Other: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma |
Estimated Enrollment: | 41 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, prior to course 2, and 60 days after completion of study treatment for pharmacokinetic and pharmacodynamic studies. Samples are analyzed by enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 41 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 confirmed stage III or IV melanoma
No evidence of CNS disease, including primary brain tumor or brain metastases
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
No concurrent uncontrolled illness, including, but not limited to any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent full-dose warfarin with PT INR > 1.5 allowed provided the following criteria are met:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
Contra Costa Regional Medical Center | |
Martinez, California, United States, 94553 | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
Veterans Affairs Outpatient Clinic - Martinez | |
Martinez, California, United States, 94553 | |
United States, Delaware | |
CCOP - Christiana Care Health Services | |
Newark, Delaware, United States, 19713 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
La Grange Memorial Hospital | |
La Grange, Illinois, United States, 60525 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | |
Peoria, Illinois, United States, 61615-7828 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 | |
United States, Pennsylvania | |
UPMC Cancer Centers | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Ahmad A. Tarhini, MD, MS | UPMC Cancer Centers |
Responsible Party: | University of California Davis Cancer Center ( David R. Gandara ) |
Study ID Numbers: | CDR0000535719, CCC-PHII-77 |
Study First Received: | March 20, 2007 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00450255 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent melanoma stage III melanoma stage IV melanoma extraocular extension melanoma |
recurrent intraocular melanoma metastatic intraocular melanoma iris melanoma ciliary body and choroid melanoma, medium/large size |
Eye Neoplasms Uveal Melanoma Eye Diseases Melanoma of the Choroid Recurrence Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Nevus |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms by Histologic Type Eye Neoplasms Eye Diseases |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |