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

Primary Purpose

Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ziv-aflibercept
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

25 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 1, 2016
Sponsor
Regeneron Pharmaceuticals
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045266
Brief Title
VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ziv-aflibercept

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Dupont, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Dupont J, Camastra D, Gordon MS, et al.: Phase 1 study of VEGF Trap in patients with solid tumors and lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-776, 2003.
Results Reference
result
PubMed Identifier
20028764
Citation
Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors. Clin Cancer Res. 2010 Jan 1;16(1):358-66. doi: 10.1158/1078-0432.CCR-09-2103. Epub 2009 Dec 22.
Results Reference
result

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

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