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An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma
RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
OBJECTIVES: * Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131. * Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients. * Determine the steady state concentration of VEGF Trap over time in these patients. * Determine whether patients develop antibodies to this therapy during extended exposure. OUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131. Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131. Patients are followed at approximately 30 days. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Age
25 - 120 years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
April 1, 2002
Primary Completion Date
February 1, 2007
Last Updated
June 3, 2016
ziv-aflibercept
BIOLOGICAL
Lead Sponsor
Regeneron Pharmaceuticals
Collaborators
NCT07388563
NCT05139017
Data Source & Attribution
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