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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00568048 |
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Biological: bevacizumab Drug: temozolomide Genetic: DNA methylation analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: flow cytometry Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Temozolomide Combined With Bevacizumab in Metastatic Melanoma. A Multicenter Phase II Trial |
Estimated Enrollment: | 62 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-7 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Blood is collected at baseline and on day 1 of course 2. Samples are analyzed for circulating endothelial cells and endothelial progenitor cells by flow cytometry and pro- and anti-angiogenic serum factors by ELISA. Paraffin-embedded tumor tissue is analyzed for MGMT promoter methylation status by methylation-specific PCR; MGMT protein expression by IHC; and MSH2, MSH6, and MLH-1 expression (DNA repair enzymes).
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Measurable disease, defined as at least one lesion that can be measured in at least one dimension as ≥ 20 mm (or as ≥ 10 mm if the CT slice thickness is ≤ 5 mm)
PATIENT CHARACTERISTICS:
No clinically significant (i.e., active) cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior adjuvant cytokine therapy (e.g., interleukin, interferon) or vaccine therapy and recovered
More than 10 days since prior and no concurrent full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes
Switzerland | |
Kantonsspital Graubuenden | Recruiting |
Chur, Switzerland, CH-7000 | |
Contact: Contact Person 41-81-256-6111 |
Study Chair: | Roger von Moos, MD | Kantonsspital Graubuenden |
Study ID Numbers: | CDR0000577499, SWS-SAKK-50/07, EU-20790 |
Study First Received: | December 4, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00568048 History of Changes |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma |
Bevacizumab Temozolomide Angiogenesis Inhibitors Recurrence Melanoma Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Antineoplastic Agents, Alkylating Alkylating Agents |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Bevacizumab Angiogenesis Inhibitors Temozolomide Pharmacologic Actions Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Alkylating Agents |