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

• ClinicalTrials.gov Identifier: NCT00045266
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: June 3, 2016
• Sponsor: Regeneron Pharmaceuticals
• Collaborator: National Cancer Institute (NCI)
• Information provided by: Regeneron Pharmaceuticals

Tracking Information

• First Submitted Date: September 6, 2002
• First Posted Date: January 27, 2003
• Last Update Posted Date: June 3, 2016
• Study Start Date: April 2002
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
• 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

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.

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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

• Intervention: Biological: ziv-aflibercept
• Study Arms: Not Provided

Publications *

• 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 Cancer Res. 2010 Jan 1;16(1):358-66. doi: 10.1158/1078-0432.CCR-09-2103. Epub 2009 Dec 22.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)

Eligibility 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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00045266
• Other Study ID Numbers: REGENERON-VGF-ST-0105; MSKCC-02020; CDR0000256462 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-G-02-2101
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Regeneron Pharmaceuticals
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Jakob Dupont, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Regeneron Pharmaceuticals
• Verification Date: June 2016