Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: This phase I trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.

Detailed Description
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OBJECTIVES: Primary Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. Secondary Determine the steady-state pharmacokinetics of this drug in these patients. Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients. Determine whether antibodies to this drug develop in these patients. Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients. OUTLINE: This is an open-label, multicenter, extension study. Patients receive VEGF Trap* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202) Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.

Official Title
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An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma

Conditions
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Cancer

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 non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites: Liver Soft tissue Pelvis Other site that is suitable for delayed contrast-enhancing MRI Relapsed or refractory disease Failed all conventional therapeutic options AND not amenable to existing therapeutic options Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity No prior or concurrent CNS metastases (brain or leptomeningeal) No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202) PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic No severe or uncontrolled hematologic condition Hepatic Not specified Renal No severe or uncontrolled renal condition Cardiovascular No severe or uncontrolled cardiovascular condition Pulmonary No severe or uncontrolled pulmonary condition Other No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition No other medical or psychiatric condition or adverse social circumstance that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy Not specified Endocrine therapy No concurrent adrenal corticosteroids, except low-dose replacement therapy No concurrent systemic hormonal contraceptive agents Radiotherapy Not specified Surgery Not specified Other No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed No other concurrent standard or investigational agents for this malignancy

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
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 vulvar cancer, recurrent grade 1 follicular lymphoma, stage IV grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, recurrent adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, fallopian tube cancer, ovarian sarcoma, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent endometrial carcinoma, stage IV endometrial carcinoma, recurrent uterine sarcoma, stage IV uterine sarcoma, recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian stromal cancer, recurrent vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, recurrent prostate cancer, stage IV prostate cancer, recurrent penile cancer, stage IV penile cancer, recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, recurrent bladder cancer, stage IV bladder cancer, stage IVB vulvar cancer, distal urethral cancer, proximal urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, primary peritoneal cavity cancer, 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, stage IV adult soft tissue sarcoma