Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	25 and over	NCI, Pharmaceutical / Industry	MSKCC-02020 REGENERON-VGF-ST-0105, NCI-G-02-2101, NCT00045266

Objectives

1. 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.
2. Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.
3. Determine the steady state concentration of VEGF Trap over time in these patients.
4. Determine whether patients develop antibodies to this therapy during extended exposure.

Entry Criteria

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

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

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

Expected Enrollment

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

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.

Dupont J, Camastra D, Gordon MS, et al.: Phase 1 study of VEGF Trap in patients with solid tumors and lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-776, 2003.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Jakob Dupont, MD, Protocol chair		Ph: 212-639-8984; 800-525-2225 Email: dupontj@mskcc.org

Registry Information
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
Trial Start Date		2002-04-09
Registered in ClinicalTrials.gov		NCT00045266
Date Submitted to PDQ		2002-06-26
Information Last Verified		2005-04-06
NCI Grant/Contract Number		CA08748