Completed

NCT Number: NCT00082823

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

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.

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Key information

Conditions

Cancer Adenocarcinoma Adnexal Diseases Burkitt Lymphoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Ovarian Epithelial Chronic Disease DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Epstein-Barr Virus Infections Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Liver Diseases Liver Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Diseases Penile Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Prostatic Diseases Prostatic Neoplasms Sarcoma Testicular Diseases Testicular Neoplasms Tumor Virus Infections Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Virus Diseases Vulvar Diseases Vulvar Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ziv-aflibercept

Biological

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2008
First posted: May 19, 2004
Registry last updated: Jun 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed