VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: ziv-aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ziv-aflibercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, unspecified adult solid tumor, protocol specific, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma