CancerPhase 1NCT00082823
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma
A Phase 1 study testing ziv-aflibercept in people with Cancer, run by Regeneron Pharmaceuticals at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- ziv-aflibercept
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Memorial Sloan - Kettering Cancer Center
New York, New York, 10021
About this study
Official title: An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- ziv-aflibercept
- 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
- Medical subject headings
- Neoplasms, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma, Lymphoma, Mantle-Cell, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziv-afliberceptBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2004 (estimated)
- Study startJan 2004
- Primary completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William P. Tew, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082823
- Sponsor's protocol ID
- REGENERON-VGFT-ST-0304
- Other IDs
- MSKCC-03138, CDR0000360846
- Status last verified
- Jun 2016
- First submitted
- 14 May 2004
- Last updated
- 3 Jun 2016
- Results posted
- No
Publications
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.
PubMed 19949018Wang-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.
PubMed 22002018
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term, Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT00082823
- Acronym / sponsor ID
- REGENERON-VGFT-ST-0304
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2004
- Primary completion
- May 2008 (actual)
- First posted
- 19 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziv-aflibercept | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Results publication: PubMed 19949018Lockhart 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 publication: PubMed 22002018Wang-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William P. Tew, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ziv-aflibercept in people with Cancer, run by Regeneron Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.