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Unspecified Childhood Solid Tumor, Protocol SpecificPhase 1NCT00622414

Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors

A Phase 1 study testing ziv-aflibercept in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 1 year to 21 years
What is being tested?
ziv-aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
6 sitesUnited States
Study dates
Apr 2008to Feb 2010
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 1 year to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically confirmed malignancy at original diagnosis or relapse (excluding intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of serum alpha-fetoprotein of beta-HCG)
  • Patients with recurrent or refractory solid tumors are eligible, including primary CNS tumors or patients with known CNS metastases
  • Current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Measurable or evaluable disease
  • No evidence of CNS hemorrhage on baseline MRI for patients with known CNS disease
  • Karnofsky performance status (PS) 50-100% (for patients > 10 years of age) or Lansky PS 50-100% (for patients ≤ 10 years of age)
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  • Neurologic deficits in patients with CNS tumors must have been relatively stable for a minimum of 1 week prior to study entry
  • Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients with solid tumors without bone marrow involvement must meet the following criteria:
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
  • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
  • Negative protein dipstick OR urine protein < 500 mg by 24-hour urine collection
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
  • 0.6 mg/dL for male and female patients 1 to < 2 years of age
  • 0.8 mg/dL for male and female patients 2 to < 6 years of age
  • 1.0 mg/dL for male and female patients 6 to < 10 years of age
  • 1.2 mg/dL for male and female patients 10 to < 13 years of age
  • 1.5 mg/dL (male) or 1.4 mg/dL (female) for patients 13 to < 16 years of age
  • 1.7 mg/dL (male) or 1.4 mg/dL (female) for patients ≥ 16 years of age
  • Bilirubin ≤ 1.5 times upper limit of normal (U.N.) for age
  • SEPT (ALT) ≤ 110 μ/L (approx. 2.5 times U.N.) (for the purpose of this study, the U.N. for SEPT is 45 μ/L)
  • Serum albumin ≥ 2 g/dL
  • PT/aPTT < 1.2 times U.N.
  • Patients must have a diastolic blood pressure ≤ the 95th percentile for age and gender and not be receiving treatment for hypertension
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of active graft-vs-host disease
  • No uncontrolled infection
  • No serious or nonhealing wound, ulcer, or bone fracture
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to day 1 of study treatment
  • No clinically significant cardiovascular disease within the past 6 months, including any of the following:
  • History of cerebrovascular accident
  • New York Heart Association class III-IV congestive heart failure
  • Serious cardiac arrhythmia requiring medication
  • Unstable angina pectoris
  • Pulmonary embolism
  • Deep vein thrombosis
  • Other thromboembolic events
  • No evidence of a current bleeding diathesis or coagulopathy
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study
  • No significant traumatic injury within 4 weeks prior to day 1 of study treatment
  • Must be able to comply with the safety monitoring requirements of the study in the opinion of the investigator
  • Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
  • No prior aflibercept
  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
  • At least 6 weeks since prior monoclonal antibodies
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • At least 2 months since prior stem cell transplantation or rescue
  • At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis
  • At least 4 weeks since prior major surgical procedure, laparoscopic procedure, or open biopsy and no anticipation of need for major surgical procedures during the course of the study
  • At least 48 hours since prior fine needle aspirate, central line placement, or subcutaneous port placement
  • At least 1 week since prior core biopsy
  • At least 1 week since prior and no concurrent hematopoietic growth factors
  • At least 1 week since prior and no concurrent biologic agents
  • At least 1 week since prior and no concurrent dexamethasone
  • No concurrent antihypertensive medications for blood pressure control
  • No concurrent anti-thrombotic or anti-platelet agents (e.g., warfarin [Coumadin ®],heparin, low molecular weight heparin, aspirin, and/or ibuprofen, or other NSAIDs)
  • No concurrent medications known to inhibit platelet function or known to selectively inhibit cyclooxygenase-2 activity (e.g., all antipyretic and anti-inflammatory medications except acetaminophen)
  • No other concurrent anticancer therapy, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
  • No other concurrent investigational drugs

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60614

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Columbia University Medical Center

    New York, New York, 10032

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

About this study

Official title: A Phase I Study of VEGF Trap (NSC# 724770, IND# 100137) in Children With Refractory Solid Tumors

This phase I trial is studying the side effects and best dose of aflibercept in treating young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RPTD) of aflibercept administered intravenously every 14 days in children with relapsed or refractory solid tumors.

II. To estimate the MTD or RPTD of aflibercept administered intravenously every 21 days in these patients.

III. To define and describe the toxicities of intravenous aflibercept administered on a 14-day and 21-day schedule, respectively.

IV. To characterize the pharmacokinetics of intravenous aflibercept in these patients.

SECONDARY OBJECTIVES:

  1. To define, preliminarily, the antitumor activity of intravenous aflibercept within the confines of a phase I study.

OUTLINE: This is a multicenter study.

PART 1: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined.

PART 2: Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Blood samples are collected prior to treatment on day 1 of courses 1, 2, and 5 or 6 for pharmacokinetic studies.

After completion of study treatment, patients are followed for at least 30 days.

Being tested
ziv-aflibercept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ziv-afliberceptBiological

    Also called aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap

    Given IV

Study groups in NCT00622414
Study groupRoleWhat they receive
Treatment (ziv-aflibercept)ExperimentalPART 1: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive aflibercept until the maximum tolerated dose (MTD) is determined. PART 2: Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Biological: ziv-aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose, defined as the maximum dose at which fewer than one-third of patients experience DLT during the initial 2 courses of therapy, graded according to NCI CTCAE version 3.0

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionFeb 2010

Resources

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00622414
Sponsor's protocol ID
NCI-2009-01062
Other IDs
NCI-2009-01062, COG-ADVL0714, CDR0000584050, NCI-08-C-0179, NCI-P08401, ADVL0714, ADVL0714, U01CA097452
Status last verified
Oct 2011
First submitted
22 Feb 2008
Last updated
24 Feb 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ziv-aflibercept in people with Unspecified Childhood Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 6 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?

The sponsor lists 64 inclusion and 0 exclusion criteria. 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 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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.

What does the primary outcome measure?

Maximum tolerated dose, defined as the maximum dose at which fewer than one-third of patients experience DLT during the initial 2 courses of therapy, graded according to NCI CTCAE version 3.0 (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00622414.

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 24 Feb 2014.

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