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

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

Tracking Information
First Submitted Date  ICMJE September 6, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date June 3, 2016
Study Start Date  ICMJE April 2002
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00045266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE Biological: ziv-aflibercept
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00045266
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Jakob Dupont, MD Memorial Sloan Kettering Cancer Center
PRS Account Regeneron Pharmaceuticals
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP