Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed incurable relapsed or refractory solid tumor or non-Hodgkin's lymphoma that has been treated on MSKCC-01131 - Must have completed participation in protocol MSKCC-01131 through visit 16 and have shown evidence of stable disease or complete or partial remission of tumor burden and no evidence of symptomatic deterioration - No adverse event or toxicity which resulted in discontinuation of participation in protocol MSKCC-01131 - If a patient experienced dose-limiting toxicity, then the patient must have demonstrated the ability to tolerate the same dose or a lower dose prior to entry in this study - No known or suspected squamous cell carcinoma of the lung - No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal) metastases during protocol MSKCC-01131 PATIENT CHARACTERISTICS: Age - 25 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,500/mm3 - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin at least 9.0 g/dL - No severe or uncontrolled hematologic condition Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN - PT, PTT, and INR normal Renal - Creatinine no greater than ULN - No 1+ or greater proteinuria - No severe or uncontrolled renal condition Cardiovascular - No severe or uncontrolled cardiovascular condition Pulmonary - No severe or uncontrolled pulmonary condition Other - No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap) - No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition - No severe or uncontrolled psychiatric condition or adverse social circumstance that would preclude study - No other condition that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-barrier contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) - No other concurrent immunotherapy Chemotherapy - No concurrent standard chemotherapy Endocrine therapy - No concurrent adrenal corticosteroids except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency - No concurrent systemic hormonal contraceptive agents Radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - At least 30 days since prior investigational therapy other than VEGF Trap - No concurrent standard or other investigational anticancer agents - No concurrent herbal supplements ("nutraceuticals") - No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, aspirin, or other nonsteroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2 (COX-2) inhibitors for analgesia - No concurrent COX-2 inhibitors for tumor treatment or prophylaxis


NCT ID:

NCT00045266


Primary Contact:

Study Chair
Jakob Dupont, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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