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.

Condition	Treatment or Intervention	Phase
Cancer	Drug: VEGF Trap  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: targeted fusion protein therapy	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6307,  United States; Recruiting

Study chairs or principal investigators

Jakob Dupont, MD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000360846; MSKCC-03138; REGENERON-VGFT-ST-0304; NCT00082823
Record last reviewed:  August 2004
Last Updated:  March 10, 2005
Record first received:  May 14, 2004
ClinicalTrials.gov Identifier:  NCT00082823
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08