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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific	Biological: ziv-aflibercept	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Masking:	None (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
Actual Primary Completion Date :	February 2007

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	25 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Regeneron Pharmaceuticals

National Cancer Institute (NCI)

Investigators

Study Chair:	Jakob Dupont, MD	Memorial Sloan Kettering Cancer Center

More Information

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Publications of Results:

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.

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.

ClinicalTrials.gov Identifier:	NCT00045266 History of Changes
Other Study ID Numbers:	REGENERON-VGF-ST-0105; MSKCC-02020; CDR0000256462 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-G-02-2101
First Posted:	January 27, 2003
Last Update Posted:	June 3, 2016
Last Verified:	June 2016

Keywords provided by Regeneron Pharmaceuticals:

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

Additional relevant MeSH terms:

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders	Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases