VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00045266

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Study Details

Study Description

Brief Summary

RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer.

PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific	Biological: ziv-aflibercept	Phase 1

Detailed Description

OBJECTIVES:

Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131.
Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.
Determine the steady state concentration of VEGF Trap over time in these patients.
Determine whether patients develop antibodies to this therapy during extended exposure.

OUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131.

Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131.

Patients are followed at approximately 30 days.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory Solid Tumors or Lymphoma

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed incurable relapsed or refractory solid tumor or non-Hodgkin's lymphoma that has been treated on MSKCC-01131
Must have completed participation in protocol MSKCC-01131 through visit 16 and have shown evidence of stable disease or complete or partial remission of tumor burden and no evidence of symptomatic deterioration
No adverse event or toxicity which resulted in discontinuation of participation in protocol MSKCC-01131
If a patient experienced dose-limiting toxicity, then the patient must have demonstrated the ability to tolerate the same dose or a lower dose prior to entry in this study
No known or suspected squamous cell carcinoma of the lung
No prior or concurrent new neurological symptoms or CNS (brain or leptomeningeal) metastases during protocol MSKCC-01131

PATIENT CHARACTERISTICS:

Age

25 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

WBC at least 3,500/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 g/dL
No severe or uncontrolled hematologic condition

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST and ALT no greater than 2 times ULN
Alkaline phosphatase no greater than 2 times ULN
PT, PTT, and INR normal

Renal

Creatinine no greater than ULN
No 1+ or greater proteinuria
No severe or uncontrolled renal condition

Cardiovascular

No severe or uncontrolled cardiovascular condition

Pulmonary

No severe or uncontrolled pulmonary condition

Other

No prior hypersensitivity reactions to any recombinant proteins (e.g., VEGF Trap)
No severe or uncontrolled gastrointestinal, immunological, or musculoskeletal condition
No severe or uncontrolled psychiatric condition or adverse social circumstance that would preclude study
No other condition that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-barrier contraception during and for at least 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF)
No other concurrent immunotherapy

Chemotherapy

No concurrent standard chemotherapy

Endocrine therapy

No concurrent adrenal corticosteroids except low doses as replacement therapy in patients who have previously received suppressive doses or for adrenal insufficiency
No concurrent systemic hormonal contraceptive agents

Radiotherapy

No concurrent radiotherapy

Surgery

Not specified

Other

At least 30 days since prior investigational therapy other than VEGF Trap
No concurrent standard or other investigational anticancer agents
No concurrent herbal supplements ("nutraceuticals")
No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, aspirin, or other nonsteroidal anti-inflammatory drugs) except selective cyclo-oxygenase-2 (COX-2) inhibitors for analgesia
No concurrent COX-2 inhibitors for tumor treatment or prophylaxis