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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Biological: ziv-aflibercept

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00082823

CDR0000360846 (Registry Identifier)

REGENERON-VGFT-ST-0304

MSKCC-03138

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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