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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045266
• Other study ID #: REGENERON-VGF-ST-0105
• Secondary ID: MSKCC-02020CDR00
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2002
• Last updated: June 1, 2016
• Start date: April 2002

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: 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 120 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• ziv-aflibercept

Locations

Country	Name	City	State
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)

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.

Tew WP, Gordon M, Murren J, Dupont J, Pezzulli S, Aghajanian C, Sabbatini P, Mendelson D, Schwartz L, Gettinger S, Psyrri A, Cedarbaum JM, Spriggs DR. Phase 1 study of aflibercept administered subcutaneously to patients with advanced solid tumors. Clin Ca — View Citation