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Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Primary Purpose

Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ziv-aflibercept
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring recurrent grade 1 follicular lymphoma, stage IV grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, recurrent adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, fallopian tube cancer, ovarian sarcoma, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent endometrial carcinoma, stage IV endometrial carcinoma, recurrent uterine sarcoma, stage IV uterine sarcoma, recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian stromal cancer, recurrent vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, recurrent prostate cancer, stage IV prostate cancer, recurrent penile cancer, stage IV penile cancer, recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, recurrent bladder cancer, stage IV bladder cancer, recurrent vulvar cancer, stage IVB vulvar cancer, distal urethral cancer, proximal urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, primary peritoneal cavity cancer, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites: Liver Soft tissue Pelvis Other site that is suitable for delayed contrast-enhancing MRI Relapsed or refractory disease Failed all conventional therapeutic options AND not amenable to existing therapeutic options Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity No prior or concurrent CNS metastases (brain or leptomeningeal) No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202) PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic No severe or uncontrolled hematologic condition Hepatic Not specified Renal No severe or uncontrolled renal condition Cardiovascular No severe or uncontrolled cardiovascular condition Pulmonary No severe or uncontrolled pulmonary condition Other No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition No other medical or psychiatric condition or adverse social circumstance that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy Not specified Endocrine therapy No concurrent adrenal corticosteroids, except low-dose replacement therapy No concurrent systemic hormonal contraceptive agents Radiotherapy Not specified Surgery Not specified Other No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed No other concurrent standard or investigational agents for this malignancy

Sites / Locations

  • Memorial Sloan - Kettering Cancer Center
  • Vanderbilt-Ingram Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 14, 2004
Last Updated
June 1, 2016
Sponsor
Regeneron Pharmaceuticals
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00082823
Brief Title
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Official Title
An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the cancer. PURPOSE: This phase I trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Primary Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma. Secondary Determine the steady-state pharmacokinetics of this drug in these patients. Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients. Determine whether antibodies to this drug develop in these patients. Determine, preliminarily, the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients. OUTLINE: This is an open-label, multicenter, extension study. Patients receive VEGF Trap* IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. NOTE: *Patients receive the same drug dose that they received in MSKCC-03137 (VGFT-ST-0202) Patients are followed monthly for 3 months. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3-6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
recurrent grade 1 follicular lymphoma, stage IV grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, recurrent adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, unspecified adult solid tumor, protocol specific, recurrent adult soft tissue sarcoma, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, fallopian tube cancer, ovarian sarcoma, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent endometrial carcinoma, stage IV endometrial carcinoma, recurrent uterine sarcoma, stage IV uterine sarcoma, recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian stromal cancer, recurrent vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, recurrent prostate cancer, stage IV prostate cancer, recurrent penile cancer, stage IV penile cancer, recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, recurrent bladder cancer, stage IV bladder cancer, recurrent vulvar cancer, stage IVB vulvar cancer, distal urethral cancer, proximal urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, primary peritoneal cavity cancer, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
ziv-aflibercept

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed non-Hodgkin's lymphoma OR primary or metastatic solid tumor located in at least one of the following sites: Liver Soft tissue Pelvis Other site that is suitable for delayed contrast-enhancing MRI Relapsed or refractory disease Failed all conventional therapeutic options AND not amenable to existing therapeutic options Must have completed the active phase (through study visit 9) of MSKCC-03137 (VGFT-ST-0202) without experiencing dose-limiting toxicity No prior or concurrent CNS metastases (brain or leptomeningeal) No new neurological symptoms during treatment on MSKCC-03137 (VGFT-ST-0202) PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic No severe or uncontrolled hematologic condition Hepatic Not specified Renal No severe or uncontrolled renal condition Cardiovascular No severe or uncontrolled cardiovascular condition Pulmonary No severe or uncontrolled pulmonary condition Other No severe or uncontrolled gastrointestinal, immunologic, or musculoskeletal condition No other medical or psychiatric condition or adverse social circumstance that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy Not specified Endocrine therapy No concurrent adrenal corticosteroids, except low-dose replacement therapy No concurrent systemic hormonal contraceptive agents Radiotherapy Not specified Surgery Not specified Other No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors No concurrent anticoagulant or antiplatelet drugs, including warfarin, heparin, or aspirin Concurrent low-dose (i.e., 1 mg) warfarin for maintaining patency of venous access devices allowed No other concurrent standard or investigational agents for this malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William P. Tew, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan - Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19949018
Citation
Lockhart AC, Rothenberg ML, Dupont J, Cooper W, Chevalier P, Sternas L, Buzenet G, Koehler E, Sosman JA, Schwartz LH, Gultekin DH, Koutcher JA, Donnelly EF, Andal R, Dancy I, Spriggs DR, Tew WP. Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors. J Clin Oncol. 2010 Jan 10;28(2):207-14. doi: 10.1200/JCO.2009.22.9237. Epub 2009 Nov 30.
Results Reference
result
PubMed Identifier
22002018
Citation
Wang-Gillam A, Tew WP, Rothenberg ML, Dupont J, Cooper W, Sternas L, Buzenet G, Sosman JA, Spriggs DR, Lockhart AC. A phase I study of subcutaneously administered aflibercept (VEGF trap) in a new formulation in patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1958-61. doi: 10.1007/s10637-011-9753-y. Epub 2011 Oct 15.
Results Reference
result

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Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma

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