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Sponsors and Collaborators: |
Cancer Therapy and Research Center, Texas National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00387751 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of melanoma by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with sorafenib works in treating patients with unresectable stage III or stage IV malignant melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: bevacizumab Drug: sorafenib tosylate Procedure: biopsy Procedure: gene expression analysis Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: mutation analysis Procedure: pharmacological study |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II, Pharmacokinetic (PK), Pharmacodynamic (PD) and Biological Correlative Study of the Efficacy and Safety of Dual Antiangiogenic Inhibition Using Bevacizumab and Sorafenib in Patients With Advanced Malignant Melanoma |
Estimated Enrollment: | 45 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive oral sorafenib tosylate on days 1-5, 8-12, 15-19, and 22-26 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Blood samples and tumor biopsies are obtained periodically for pharmacokinetic and pharmacodynamic studies. Samples are examined by liquid chromatography, mass spectrometry, immunohistochemistry, gene expression analysis, DNA mutation analysis, and genomic analysis for biological markers.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 45 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 melanoma
Measurable disease, defined as ≥ 1 lesion that can be accurately and serially measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
No active CNS metastatic brain or meningeal tumors
PATIENT CHARACTERISTICS:
None of the following medical conditions:
PRIOR CONCURRENT THERAPY:
No more than 2 prior immunotherapy, cytokine therapy, biologic therapy, or vaccine therapy regimens (e.g., aldesleukin) for advanced or metastatic disease
No chemotherapy or radiotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) and recovered
Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 allowed provided the following criteria are met:
United States, Texas | |
Brooke Army Medical Center | Recruiting |
Fort Sam Houston, Texas, United States, 78234-6200 | |
Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837 | |
Cancer Therapy and Research Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Clinical Trials Office - Cancer Therapy and Research Center 210-616-5798 |
Study Chair: | Muralidhar Beeram, MD | Cancer Therapy and Research Center, Texas |
Study ID Numbers: | CDR0000502282, CTRC-05-25, NCI-7200, CTRC-056-5011-233 |
Study First Received: | October 12, 2006 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00387751 |
Health Authority: | Unspecified |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Bevacizumab |
Nevus Sorafenib Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas Angiogenesis Modulating Agents Growth Inhibitors |