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Sponsors and Collaborators: |
University of Virginia National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00397982 |
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. 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 malignant melanoma by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temsirolimus together with bevacizumab works in treating patients with stage III or stage IV malignant melanoma.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: bevacizumab Drug: temsirolimus Procedure: biopsy Procedure: conventional surgery Procedure: flow cytometry Procedure: immunohistochemistry staining method Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: molecular genetic technique Procedure: mutation analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of CCI-779 in Combination With Bevacizumab in Stage III or IV Melanoma |
Estimated Enrollment: | 23 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor resection on day 9 of course 2.
Blood samples are collected during courses 1 and 2. Samples are examined by flow cytometry to evaluate peripheral blood mononuclear cells for molecular effects of study agents. Patients also undergo normal and tumor tissue biopsy (by core needle biopsy, incisional biopsy, or surgical resection) during courses 1 and 2. Samples are examined by immunohistochemistry, western blotting, protein array technology, gene expression analyses, DNA mutation analyses, and genomic analyses for pre- and post-treatment measurements of target molecules (epidermal growth factor receptor, B-Raf, MEK, MAPK), downstream pathway components (PI-3 kinase, AKT, mTOR), markers of angiogenesis, proliferation and apoptosis, markers that may modulate cell signaling or the response to investigational agents, and vascular and immune system parameters.
After completion of study treatment, patients are followed at 1 month, every 3 months for up to 2 years, and then periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 23 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 measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan
Prior brain metastases allowed provided all of the following criteria are met:
More than 30 days since prior steroids for managing brain metastases
Disease accessible for core needle biopsy, incisional biopsy, and/or surgical resection and meets one of the following criteria:
Multiple deposits that can be biopsied or excised individually on different dates, measured as follows:
PATIENT CHARACTERISTICS:
None of the following within the past 4 weeks:
No clinically significant cardiovascular disease, including the following:
No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
More than 4 weeks since any of the following prior treatments and recovered:
Concurrent full-dose anticoagulants (e.g., warfarin/low molecular weight heparin) with PT INR > 1.5 are allowed provided the following criteria are met:
No active, clinically significant bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following:
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790 | |
United States, Virginia | |
University of Virginia Cancer Center | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Craig L. Slingluff, MD 434-982-6714 cls8h@virginia.edu |
Study Chair: | Craig L. Slingluff, MD | University of Virginia |
Study ID Numbers: | CDR0000512836, UVACC-MEL-47, NCI-7190 |
Study First Received: | November 9, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00397982 |
Health Authority: | Unspecified |
stage III melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Bevacizumab Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |