Completed

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

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What is being tested

ziv-aflibercept

Biological
Who is being recruted

Cancer

From 18 to 120 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2004

See protocol details

Summary

Principal SponsorRegeneron Pharmaceuticals
Last updated: June 3, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

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. 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 TitleAn Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma 
Principal SponsorRegeneron Pharmaceuticals
Last updated: June 3, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cancer
Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Memorial Sloan - Kettering Cancer CenterNew York, United StatesSee the location
Suspended
Vanderbilt-Ingram Cancer CenterNashville, United States
Completed2 Study Centers