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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074308 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bevacizumab Drug: imatinib mesylate |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study Of Imatinib Mesylate And Bevacizumab In Patients With Advanced Melanoma And Other Advanced Cancers |
Estimated Enrollment: | 64 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation, open-label study.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab 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.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 6 months (phase I study closed to accrual as of 8/23/04). A total of 23-40 patients will be accrued for the phase II portion of this study within 10 months.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed diagnosis of 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled hypertension within the past 6 months
None of the following within the past 6 months:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Principal Investigator: | Keith T. Flaherty, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000343804, UPCC-03903, NCI-6006 |
Study First Received: | December 10, 2003 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00074308 |
Health Authority: | United States: Food and Drug Administration |
stage III melanoma stage IV melanoma recurrent melanoma unspecified adult solid tumor, protocol specific |
Imatinib Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Bevacizumab Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents |