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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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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 |
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Intraocular Melanoma Melanoma (Skin) |
Drug: aflibercept Procedure: immunoenzyme technique Procedure: 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 Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
Contra Costa Regional Medical Center | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Sharon Hiner, MD 925-370-5114 shiner@hsd.co.contra-costa.ca.us | |
Tower Cancer Research Foundation | Recruiting |
Beverly Hills, California, United States, 90211 | |
Contact: Solomon I. Hamburg, MD, PhD 310-888-8680 | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
Veterans Affairs Outpatient Clinic - Martinez | Recruiting |
Martinez, California, United States, 94553 | |
Contact: Nelson J. Lim, MD 925-372-2062 nelson.lim@med.va.gov | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 |
Study Chair: | Ahmad A. Tarhini, MD, MS | UPMC Cancer Centers |
Study ID Numbers: | CDR0000535719, CCC-PHII-77 |
Study First Received: | March 20, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00450255 |
Health Authority: | Unspecified |
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 Eye Diseases Recurrence Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors |
Uveal melanoma Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Nevus |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |