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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082823
• Other study ID #: REGENERON-VGFT-ST-0304
• Secondary ID: MSKCC-03138CDR00
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2004
• Last updated: June 1, 2016
• Start date: January 2004

Study information

• Verified date: June 2016
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• ziv-aflibercept

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Memorial Sloan - Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lockhart AC, Rothenberg ML, Dupont J, Cooper W, Chevalier P, Sternas L, Buzenet G, Koehler E, Sosman JA, Schwartz LH, Gultekin DH, Koutcher JA, Donnelly EF, Andal R, Dancy I, Spriggs DR, Tew WP. Phase I study of intravenous vascular endothelial growth fac — View Citation

Wang-Gillam A, Tew WP, Rothenberg ML, Dupont J, Cooper W, Sternas L, Buzenet G, Sosman JA, Spriggs DR, Lockhart AC. A phase I study of subcutaneously administered aflibercept (VEGF trap) in a new formulation in patients with advanced solid tumors. Invest — View Citation