VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's 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.
|Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Biological: ziv-aflibercept||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma|
|Study Start Date:||April 2002|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045266
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Jakob Dupont, MD||Memorial Sloan Kettering Cancer Center|