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Astrocytoma, Oligoastrocytoma, MixedPhase 1NCT01999270

Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors

A Phase 1 study testing Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging in people with Astrocytoma, Oligoastrocytoma, Mixed and Ganglioneuroma, run by Washington University School of Medicine at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab. Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Apr 2013to May 2016
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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patient must have histological verification of one of the eligible diagnosis listed below. Biopsy is required at time of diagnosis, with the exception of optic pathway tumors. Patients with spinal cord disease are eligible if they have a lesion >1 cm in 2 dimensions. The following histologies are eligible:
  • Astrocytoma variants: fibrillary, protoplasmic, mixed
  • Pilocytic astrocytoma, including pilomyxoid variants
  • Pleomorphic xanthoastrocytoma
  • Infantile desmoplastic astrocytoma
  • Ganglioneuroma
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  • Oligodendroglial tumor
  • Mixed glioma (including oligoastrocytoma)
  • Anaplastic astrocytoma
  • Anaplastic oligoastrocytoma
  • Anaplastic oligodendroglioma
  • Anaplastic ganglioglioma
  • Glioblastoma multiforme (including giant cell and gliosarcoma types)
  • Medulloblastoma
  • Ependymoma
  • Other rare malignant CNS tumors (i.e., pineal blastoma, small cell astrocytoma, etc.)
  • Patient must be ≤ 21 years of age at time of study enrollment.
  • Patient must have measurable residual disease, defined as tumor that is measurable in two perpendicular diameters on MRI. Diffuse leptomeningeal disease is not considered measurable.
  • Patient must have a Lansky or Karnofsky performance of >40% corresponding to ECOG categories 0, 1, or 2. Karnofsky will be used for patients >16 years of age and Lansky for patients <16 years of age. 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.
  • Patient must have a life expectancy of >8 weeks.
  • Patient must have fully recovered from the acute toxic effects of all prior chemotherapy or radiation prior to entering this study.
  • Patient must have recovered from any surgical procedure before enrolling on this study.
  • Hypertensive patients are eligible provided the hypertension is well controlled (95th percentile for age and height if patient ≤17 years) on stable doses of medication. (See Appendices I and II for tables of blood pressure based on age and gender).
  • Patients receiving corticosteroids are eligible provided the dose is stable or decreasing for at least 7 days.
  • Patient must have adequate bone marrow function (including status post-SCT) defined as:
  • Peripheral absolute neutrophil count (ANC) ≥1000/uL (must not have received G-CSF within the prior 7 days)
  • Platelet count ≥ 100,000/uL (transfusion independent)
  • Hemoglobin ≥ 8.0 gm/dL (may receive pRBC transfusions)
  • Patient must have adequate renal function defined as:
  • Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or
  • A serum creatinine based on age/gender as follows:
  • 1 month to < 6 months, male max 0.4, female max 0.4
  • 6 months to < 1 year, male max 0.5, female max 0.5
  • 1 to <2 years, male max 0.6, female max 0.6
  • 2 to < 6 years, male max 0.8, female max 0.8
  • 6 to <10 years, male max 1.0, female max 1.0
  • 10 to <13 years, male max 1.2, female max 1.2
  • 13 to <16 years, male max 1.5, female max 1.4
  • 16 years, male max 1.7, female max 1.4
  • Urine protein should be screened by dipstick analysis. If protein ≥ 2+ on dipstick, then Urine Protein Creatinine (UPC) ratio should be calculated. If UPC ratio >1, 24-hour urine protein should be obtained and the level should be <1000 mg/24 hours for patient enrollment.
  • Note: UPC ratio of spot urine is an estimation of the 24 hour urine protein excretion- a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using of the following formulae:
  • [urine protein]/[urine creatinine] - if both protein and creatinine are reported in mg/dL [(urine protein x 0.088]/[urine creatinine] - if urine creatinine is reported in mmol/L
  • Patient must have adequate liver function defined as:
  • Total bilirubin ≤1.5x upper limit of normal for age (ULN)
  • SGPT (ALT) ≤ 2.5 x the upper limit of normal (ULN) for age
  • Patients with a seizure disorder are eligible if well-controlled on anticonvulsants. If on a non-enzyme inducing anticonvulsant, the irinotecan dose will be adjusted as outline in treatment plan.
  • Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy.
  • Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.

Who cannot join

  • Patient must not have had myelosuppressive chemotherapy ≤ 3 weeks prior to entry onto this study (or 6 weeks if prior nitrosourea).
  • Patient must not have had any anti-neoplastic biologic agent ≤7 days prior to entry onto this study (or at least 3 half-lives for biologic agents with a long half-life).
  • Patient must not have received craniospinal radiotherapy or involved field radiotherapy to the local tumor (and/or tumor designated as "measurable" for protocol purposes) ≤ 24 weeks prior to study entry; focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry.
  • Patient must not have received bevacizumab, or other anti-VEGF inhibitor in the last 3 months.
  • Patient must not require a major surgical procedure ≤ 21 days prior to beginning therapy.
  • Patient must not require an intermediate surgical procedure ≤14 days prior to beginning therapy.
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  • Patient must not require a minor surgical procedure (i.e., Broviac line or infusaport placement) ≤ 7 days prior to beginning therapy, and the wound must be healed prior to initiation of therapy.
  • There should be no anticipation of need for major surgical procedures during the course of the study.
  • Patient must not have received any growth factors ≤7 days of entry onto this study.
  • Patient must not be taking NSAIDS, clopidogrel, dipyridamole, or aspirin therapy >81 mg/day.
  • Patient must not have a serious or non-healing wound, ulcer, or bone fracture.
  • Patient must not require sedation for imaging purposes.
  • Patient must not be receiving an investigational drug.
  • Patient must not be receiving any other anti-cancer agent.
  • Patient must not have an uncontrolled infection.
  • Patient must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess ≤ 6 months prior to study entry.
  • Patient must not have a known bleeding diathesis or coagulopathy.
  • Patient must not have had significant vascular disease (e.g., Moya-Moya, aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) ≤ 6 months prior to study entry.
  • Patient must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia, or antiphospholipid antibody syndrome). Testing is not required in patients without a thrombophilic history.
  • Patient must not have evidence of a new CNS hemorrhage greater than 0.5cm on baseline MRI obtained ≤ 14 days prior to study enrollment.
  • Patient must not have a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure ≤ 6 months prior to study entry.
  • Patient must not have serious and inadequately controlled cardiac arrhythmia
  • Patient must not be pregnant or breastfeeding.
  • Patient must not have a known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
  • Patient must not be known to be HIV-positive on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with study therapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Patient must not have any contraindications to MRI imaging including implanted medical devices and metal objects which may be adversely affected by MRI imaging. All subjects will be required to complete a standard MRI screening form prior to imaging.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors, A Feasibility Study

To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.

Read the detailed description

Evaluate the feasibility of using FDOPA-PET/MRI pediatric patients with CNS tumors. Positive results in this small study would provide the data needed to expand the study to validate the use in a larger population of pediatric patients. Validating the use of FDOPA-PET imaging as an early predictor for response to anti-angiogenic therapy could greatly impact the standard of care for treating and evaluating pediatric brain tumors and provide a useful biomarker for assessing experimental therapeutics.

Being tested
Irinotecan, Bevacizumab, FDOPA-PET/MRI imaging
Medical subject headings
Astrocytoma, Ganglioneuroma, Glioma, Ganglioglioma

What participants receive

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

  • IrinotecanDrug

    Also called Camptosar®, CPT-11

    Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29)

    Note: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.

  • BevacizumabDrug

    Also called Avastin®

    Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.

  • FDOPA-PET/MRI imagingDevice

    FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse

Study groups in NCT01999270
Study groupRoleWhat they receive
Irinotecan, Bevacizumab and FDOPA-PET/MRI imagingExperimentalIrinotecan can be removed from the treatment plan at the discretion of the healthcare provider.
Receives: Drug: Irinotecan; Drug: Bevacizumab; Device: FDOPA-PET/MRI imaging

What is being measured

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

  1. FDOPA-PET/MRI imaging

    The imaging is evaluated: (a) the uptake of PET tracer FDOPA measured by average and maximal standardized uptake values (SUVs) as well as tumor to normal brain ratios; and (b) tumor volumes defined by MRI signal abnormality.

    Measured: 1 year

Timeline

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

  1. First posted3 Dec 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2016
  4. Study completionMay 2016

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01999270
Sponsor's protocol ID
201303069
Status last verified
Oct 2016
First submitted
25 Nov 2013
Last updated
21 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging in people with Astrocytoma, Oligoastrocytoma, Mixed and Ganglioneuroma, run by Washington University School of Medicine at 1 site 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 48 inclusion and 26 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

FDOPA-PET/MRI imaging (time frame: 1 year). 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 NCT01999270.

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 21 Oct 2016.

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