Trial record 2 of 2 for:    "Ganglioglioma"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01999270
First received: November 25, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Astrocytoma, Oligoastrocytoma, Mixed
Ganglioneuroma
Glioma
Ganglioglioma
Glioblastoma Multiforme Glioma
Drug: Irinotecan
Drug: Bevacizumab
Device: FDOPA-PET/MRI imaging
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors, A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • FDOPA-PET/MRI imaging [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 5
Study Start Date: April 2013
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging
Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.
Drug: Irinotecan

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.

Other Names:
  • Camptosar®
  • CPT-11
Drug: Bevacizumab
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.
Other Name: Avastin®
Device: FDOPA-PET/MRI imaging
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

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Oligodenroglial 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:

      1. Peripheral absolute neutrophil count (ANC) ≥1000/uL (must not have received G-CSF within the prior 7 days)
      2. Platelet count ≥ 100,000/uL (transfusion independent)
      3. Hemoglobin ≥ 8.0 gm/dL (may receive pRBC transfusions)
    • Patient must have adequate renal function defined as:

      a. Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or b. A serum creatinine based on age/gender as follows: NOTE: for MRI imaging serum creatinine measurement must meet the same criteria and be measured within 1 week of the imaging session Age Maximum Serum Creatinine (mg/dL) Male Female

      1 month to < 6 months 0.4 0.4 6 months to < 1 year 0.5 0.5

      1. to <2 years 0.6 0.6
      2. to < 6 years 0.8 0.8

      6 to <10 years 1.0 1.0 10 to <13 years 1.2 1.2 13 to <16 years 1.5 1.4

      ≥16 years 1.7 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J.Peds 106:522, 1985) utilizing child length and stature data published by the CDC.

    • 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:

    1. Total bilirubin ≤1.5x upper limit of normal for age (ULN)
    2. SGPT (ALT) ≤ 2.5 x the upper limit of normal (ULN) for age
  • Patient must have adequate coagulation defined as:

    a. INR/PT <1.5 x upper limits of normal

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Examples of Major, Intermediate, or Minor Surgical Procedures

Major Procedures Intermediate Procedures Minor Procedures Organ resection VP-shunt placement Incision drainage of superficial skin abscesses Bowel wall anastomosis Stereotactic brain biopsy Punch biopsy of skin lesions Arteriovenous grafts Paracentesis or thoracentesis Superficial skin wound suturing Exploratory laparotomy Bone marrow aspirate and/or biopsy Thoracotomy Fine needle aspirations Broviac line or infusaport placement

Note: Lumbar punctures or placement of PICC lines are not considered minor procedures and may occur at any time prior to or during therapy.

  • 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 contra-indications 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.

Inclusion of Female Patients and Minorities

Both male and female patients and members of all races and ethnic groups are eligible for this trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999270

Contacts
Contact: Karen Gauvain, M.D. 314-286-2790 Gauvain_K@kids.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Karen Gauvain, M.D.    314-286-2790    Gauvain_K@kids.wustl.edu   
Sub-Investigator: Jonathan McConathy, M.D., Ph.D.         
Sub-Investigator: Joshua Rubin, M.D., Ph.D         
Sub-Investigator: Jeffrey Leonard, M.D.         
Sub-Investigator: Robert McKinstry, M.D.         
Sub-Investigator: Robert Hayashi, M.D.         
Sub-Investigator: Amy Barone, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Karen Gauvain, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01999270     History of Changes
Other Study ID Numbers: 201303069
Study First Received: November 25, 2013
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ganglioglioma
Astrocytoma
Ganglioneuroma
Ganglioneuroblastoma
Glioblastoma
Glioma
Central Nervous System Neoplasms
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Irinotecan
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014