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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390156 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell 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. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab and cyclophosphamide may also stop the growth of tumor cells by blocking blood flow to the tumor. Imatinib mesylate and bevacizumab may help cyclophosphamide work better by making tumor cells more sensitive to the drug. Giving cyclophosphamide once a day together with imatinib mesylate and bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with bevacizumab and cyclophosphamide in treating patients with refractory metastatic solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Biological: bevacizumab Drug: cyclophosphamide Drug: imatinib mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I Trial of Imatinib Mesylate, Bevacizumab, & Metronomic Cyclophosphamide as Antiangiogenic Therapy in Refractory Metastatic Solid Tumors |
Estimated Enrollment: | 21 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, pilot, dose-escalation study of imatinib mesylate.
Patients receive oral cyclophosphamide and oral imatinib mesylate once daily on days 1-28 and bevacizumab IV on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 21 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:
Diagnosis of solid tumor
No lung malignancy with any of the following characteristics:
PATIENT CHARACTERISTICS:
No uncontrolled cardiovascular disease, including any of the following:
No arterial thromboses within the past year, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-1705 |
Study Chair: | Emily K. Bergsland, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000508991, UCSF-06991, UCSF-H9672-28868-01 |
Study First Received: | October 18, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00390156 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Imatinib Immunologic Factors Antineoplastic Agents, Alkylating Bevacizumab Cyclophosphamide |
Antirheumatic Agents Protein Kinase Inhibitors Alkylating Agents Immunosuppressive Agents Angiogenesis Inhibitors |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Cyclophosphamide Bevacizumab Angiogenesis Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Imatinib Therapeutic Uses Myeloablative Agonists Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |